Irritable Bowel Syndrome
Conditions
Brief summary
This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.
Interventions
OTHERa low FODMAP diet for 4 weeks
low FODMAP diet for 4 weeks
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Patients with diarrhea predominant IBS (IBS-D) will undergo 4 weeks of low FODMAP diet. Urine, blood, stool, and colon biopsies will be collected before and after the diet to assess changes in gut physiology.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms. * Normal stool studies including, ova and parasites since the onset of symptoms * IBS-SSS score of ≥175 at the end of the 7-day screening period In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.
Exclusion criteria
* individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months * individuals with any known food allergy or insulin-dependent diabetes * known history of celiac disease, inflammatory bowel disease or microscopic colitis * prior small bowel or colonic surgery or cholecystectomy * pregnant patients * Antibiotics in the past 3 months * Those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactulose Mannitol Excretion | 4 weeks | Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Epithelial Permeability - Tight Junction Gene Expression | 4 weeks | Changes in tight junction (TJ) gene expression in colonic biopsies before and after low FODMAP diet Gene expression of Tight junction proteins were normalized to that of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH). |
| Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4 weeks | Changes in Quantitative tight junction immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet Data is reported as ratio of TJ proteins to NA-K ATPase. |
| Changes in Stool Microbiome - Alpha Diversity | 4 weeks | Changes in relative abundance of bacteria before and after low FODMAP diet. Alpha diversity was measured as number of Amplicon Sequence Variant (ASV) measured in the specimen. |
| Immunohistochemistry for Mast Cells | 4 weeks | Number of mast cells in sample after immunohistochemistry were counted. |
| Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | 4 weeks | PROMIS scales of Belly pain (5a) and diarrhea (6a) will be administered to assess the severity of belly pain and diarrhea in our patients. PROMIS Belly pain questionnaire and PROMIS diarrhea questionnaire have five and six questions, respectively, which assess symptom severity on a 5 point Likert scale. 50 indicates the general population mean with a standard deviation of 10. Higher T-scores on these questionnaires refer to more severe gastrointestinal symptoms. PROMIS belly pain asks how often did you have belly pain, severity of belly pain, interference with activities, bothersomeness and discomfort. PROMIS diarrhea asks how many days did you have loose stools, interference with activities, bothersomeness, and how often you experience urgency. |
| Changes in Stool Microbiome - Beta Diversity | 4 weeks | Changes in relative abundance of bacteria before and after low FODMAP diet. For the beta diversity, an analysis of similarities (ANOSIM)test based on Bray-Curtis distances is the best measure if the communities were different. The ANOSIM R statistic gives the scale of difference. ANOSIM R ranges from -1 to 1, where 1 means there is most interparticipant similarity within the group compared with between the different groups, and where -1 means there is least interparticipant similarity within the group compared with between the different groups. A value close to 0 indicates no significant difference between groups, meaning the dissimilarity is similar both within and between groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week | 4 weeks | Measure Description: IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity. Participants were separated into arms based on the change in their responses from baseline to 4 weeks. |
Countries
United States
Participant flow
Pre-assignment details
All participants began the same 4-week Low FODMAP diet treatment. Once participants completed the 4-week intervention, they were categorized based on the changes in their IBSSS survey responses. Data was analyzed for each group separately. Participants who did not submit their IBSSS surveys after 4-weeks of treatment could not be placed in either group, submitted no data, and are not considered to have completed the trial.
Participants by arm
| Arm | Count |
|---|---|
| Responders Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points. | 34 |
| Non-Responders Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points. | 8 |
| Intervention Recipients Who Did Not Complete the Trial These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into responders or non-responders. | 6 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Total | Responders | Non-Responders | Intervention Recipients Who Did Not Complete the Trial |
|---|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 11.5 | 38.3 years STANDARD_DEVIATION 11.2 | 44.6 years STANDARD_DEVIATION 11.8 | 32.2 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 32 Participants | 8 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) | 317.4 score on a scale STANDARD_DEVIATION 86.2 | 334.2 score on a scale STANDARD_DEVIATION 81.36 | 254.5 score on a scale STANDARD_DEVIATION 65.52 | 303.6 score on a scale STANDARD_DEVIATION 113.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 24 Participants | 8 Participants | 3 Participants |
| Region of Enrollment United States | 48 Participants | 34 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Female | 35 Participants | 23 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 2 / 34 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 34 | 0 / 8 | 0 / 6 |
Outcome results
Primary
Lactulose Mannitol Excretion
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h
Time frame: 4 weeks
Population: No data was collected from Intervention Recipients Who Did Not Complete The Trial arm
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Responders | Lactulose Mannitol Excretion | Baseline - Lactulose Excretion | 512.5 micrograms per ml |
| Responders | Lactulose Mannitol Excretion | Baseline - Mannitol Excretion | 41395 micrograms per ml |
| Responders | Lactulose Mannitol Excretion | 4-Week - Mannitol Excretion | 37030 micrograms per ml |
| Responders | Lactulose Mannitol Excretion | 4-Week - Lactulose Excretion | 456.8 micrograms per ml |
| Non-Responders | Lactulose Mannitol Excretion | 4-Week - Mannitol Excretion | 54825 micrograms per ml |
| Non-Responders | Lactulose Mannitol Excretion | Baseline - Lactulose Excretion | 394.5 micrograms per ml |
| Non-Responders | Lactulose Mannitol Excretion | 4-Week - Lactulose Excretion | 411 micrograms per ml |
| Non-Responders | Lactulose Mannitol Excretion | Baseline - Mannitol Excretion | 86820 micrograms per ml |
Secondary
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
Changes in Quantitative tight junction immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet Data is reported as ratio of TJ proteins to NA-K ATPase.
Time frame: 4 weeks
Population: No data was analyzed for the Intervention Recipients Who Did Not Complete The Trial arm because those participants did not submit second sample.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - ZO-1 | 0.06579 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - Occludin | 2.623 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - JAM-A | 0.07493 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - Occludin | 5.529 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - Claudin-1 | 6.542 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - ZO-1 | 0.07330 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - Claudin-1 | 11.22 ratio of TJ proteins to NA-K ATPase |
| Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - JAM-A | 0.09149 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - Claudin-1 | 9.218 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - ZO-1 | 0.03703 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - ZO-1 | 0.05063 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - JAM-A | 0.08437 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - JAM-A | 0.07267 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - Occludin | 3.834 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Baseline - Claudin-1 | 10.40 ratio of TJ proteins to NA-K ATPase |
| Non-Responders | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | 4-week - Occludin | 5.533 ratio of TJ proteins to NA-K ATPase |
Secondary
Changes in Epithelial Permeability - Tight Junction Gene Expression
Changes in tight junction (TJ) gene expression in colonic biopsies before and after low FODMAP diet Gene expression of Tight junction proteins were normalized to that of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Time frame: 4 weeks
Population: No data was analyzed for the Intervention Recipients Who Did Not Complete The Trial arm because those participants did not submit second sample.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - ZO-1 | .9 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - ZO-1 | 1.4 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - JAM-A | 0.9 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - JAM-A | 2 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - Occludin | 0.9 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - Occludin | 1.3 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - Claudin-1 | 0.6 ratio of TJ proteins to GAPDH |
| Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - Claudin-1 | 1.1 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - Claudin-1 | 0.9 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - ZO-1 | .7 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - Occludin | 0.6 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - ZO-1 | 1.1 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - Claudin-1 | 0.5 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | Baseline - JAM-A | 0.5 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - Occludin | 0.8 ratio of TJ proteins to GAPDH |
| Non-Responders | Changes in Epithelial Permeability - Tight Junction Gene Expression | 4-week - JAM-A | 1.3 ratio of TJ proteins to GAPDH |
Secondary
Changes in Stool Microbiome - Alpha Diversity
Changes in relative abundance of bacteria before and after low FODMAP diet. Alpha diversity was measured as number of Amplicon Sequence Variant (ASV) measured in the specimen.
Time frame: 4 weeks
Population: No data was analyzed for the Intervention Recipients Who Did Not Complete the Trial arm because participants did not submit necessary samples for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Responders | Changes in Stool Microbiome - Alpha Diversity | Baseline - Alpha Diversity | 649.087 ASVs Observed | Standard Deviation 160.1794 |
| Responders | Changes in Stool Microbiome - Alpha Diversity | 4-week - Alpha Diversity | 599.7391 ASVs Observed | Standard Deviation 159.1749 |
| Non-Responders | Changes in Stool Microbiome - Alpha Diversity | Baseline - Alpha Diversity | 532.75 ASVs Observed | Standard Deviation 153.69 |
| Non-Responders | Changes in Stool Microbiome - Alpha Diversity | 4-week - Alpha Diversity | 608.5 ASVs Observed | Standard Deviation 182.12 |
Secondary
Changes in Stool Microbiome - Beta Diversity
Changes in relative abundance of bacteria before and after low FODMAP diet. For the beta diversity, an analysis of similarities (ANOSIM)test based on Bray-Curtis distances is the best measure if the communities were different. The ANOSIM R statistic gives the scale of difference. ANOSIM R ranges from -1 to 1, where 1 means there is most interparticipant similarity within the group compared with between the different groups, and where -1 means there is least interparticipant similarity within the group compared with between the different groups. A value close to 0 indicates no significant difference between groups, meaning the dissimilarity is similar both within and between groups
Time frame: 4 weeks
Population: No data was analyzed for the Intervention Recipients Who Did Not Complete the Trial arm because participants did not submit necessary samples for analysis.~Some participants in both analyzed arms did not provide samples of sufficient quality for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Responders | Changes in Stool Microbiome - Beta Diversity | -0.03722 units on a scale |
| Non-Responders | Changes in Stool Microbiome - Beta Diversity | -0.2708 units on a scale |
Secondary
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)
PROMIS scales of Belly pain (5a) and diarrhea (6a) will be administered to assess the severity of belly pain and diarrhea in our patients. PROMIS Belly pain questionnaire and PROMIS diarrhea questionnaire have five and six questions, respectively, which assess symptom severity on a 5 point Likert scale. 50 indicates the general population mean with a standard deviation of 10. Higher T-scores on these questionnaires refer to more severe gastrointestinal symptoms. PROMIS belly pain asks how often did you have belly pain, severity of belly pain, interference with activities, bothersomeness and discomfort. PROMIS diarrhea asks how many days did you have loose stools, interference with activities, bothersomeness, and how often you experience urgency.
Time frame: 4 weeks
Population: Participants in the Intervention Recipients who did not Complete the Trial arm did not submit surveys at the 4-week point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline - Belly Pain | 63.6 T-score | Standard Deviation 6.2 |
| Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | 4-week - Belly Pain | 47.1 T-score | Standard Deviation 9.4 |
| Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline - Diarrhea | 61.2 T-score | Standard Deviation 10.8 |
| Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | 4-week - Diarrhea | 55.8 T-score | Standard Deviation 8.3 |
| Non-Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline - Belly Pain | 64.1 T-score | Standard Deviation 5.1 |
| Non-Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | 4-week - Diarrhea | 55.6 T-score | Standard Deviation 8.4 |
| Non-Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline - Diarrhea | 49.1 T-score | Standard Deviation 8.3 |
| Non-Responders | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | 4-week - Belly Pain | 60.8 T-score | Standard Deviation 3.1 |
| Intervention Recipients Who Did Not Complete the Trial | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline - Diarrhea | 61.3 T-score | Standard Deviation 5 |
| Intervention Recipients Who Did Not Complete the Trial | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline - Belly Pain | 63.7 T-score | Standard Deviation 6.4 |
| Intervention Recipients Who Did Not Complete the Trial | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | 4-week - Diarrhea | 0 T-score | Standard Deviation 0 |
Secondary
Immunohistochemistry for Mast Cells
Number of mast cells in sample after immunohistochemistry were counted.
Time frame: 4 weeks
Population: No data was analyzed for Intervention Recipients Who Did Not Complete the Trial, as they did not submit necessary samples.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Responders | Immunohistochemistry for Mast Cells | Baseline - Mast Cell Count | 23 mast cell count per high power field |
| Responders | Immunohistochemistry for Mast Cells | 4-Week - Mast Cell Count | 14.5 mast cell count per high power field |
| Non-Responders | Immunohistochemistry for Mast Cells | Baseline - Mast Cell Count | 26.5 mast cell count per high power field |
| Non-Responders | Immunohistochemistry for Mast Cells | 4-Week - Mast Cell Count | 11.5 mast cell count per high power field |
Other Pre-specified
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week
Measure Description: IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity. Participants were separated into arms based on the change in their responses from baseline to 4 weeks.
Time frame: 4 weeks
Population: Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they were sorted into the third arm and not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Responders | Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week | 87.7 score on a scale | Standard Deviation 84.8 |
| Non-Responders | Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week | 235.4 score on a scale | Standard Deviation 72.12 |