Irritable Bowel Syndrome, Irritable Bowel Syndrome Mixed, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
Síndrome del intestino irritable, Piña, Nuez, Guayaba, Intestino, Suplemento dietético, Antiinflamación, Efecto digestivo, Digestión
Brief summary
Irritable bowel syndrome is characterized by the presence of chronic, recurrent abdominal pain, alterations in bowel habits, and abdominal distension. The medical diagnosis is made using the Rome IV criteria. There are three IBS phenotypes: diarrhea-predominant, constipation-predominant, and mixed.
Detailed description
A sample of 100 people will be supplemented, with 50 participants consuming the nutraceutical gel and the remaining 50 receiving a placebo supplement. The supplementation period lasts 14 days, during which severity questionnaires and the Bristol Stool Scale will be administered on Day 0, Day 7, and Day 14. Additionally, to assess biomarkers, biochemical tests for PCR, calprotectin, and fecal lactoferrin will be conducted.
Interventions
DIETARY_SUPPLEMENTAnaná
The supplement consists of a box containing 14 sachets of the product for 14 days of treatment. Patients should preferably consume the supplement in the morning. The Ananá's Nutraceutical Group will receive the real supplement for consumption over 14 days, while the Ananá's Placebo Group will receive a placebo supplement for comparison at the end of the trial.
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
For the purposes of the study, it was decided to use a double-blind method, where neither the investigator nor the patient knows which treatment is the nutraceutical and which is the placebo. To achieve this, the team was responsible for mixing the treatment packages to allow for proper distribution.
Intervention model description
Comparison between two groups: nutraceutical and placebo treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be over 18 years old. * Be an employee or beneficiary of UANL. * Have gastrointestinal alterations (diarrhea, constipation, etc.) that suggest the presence of irritable bowel syndrome. * Not be under any medical treatment.
Exclusion criteria
* Being under medical treatment. * Not having gastrointestinal alterations much as diarrhea, constipation, etc. * being under 18 years old. * Not being an employee or beneficiary of UANL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the Consumption of a Nutraceutical Composition on Signs and Symptoms in Adult Patients with Irritable Bowel Syndrome. | 1 year | A sample of 100 people will be supplemented, with 50 participants consuming the nutraceutical gel and the remaining 50 receiving a placebo supplement. The supplementation period lasts 14 days, during which severity questionnaires and the Bristol Stool Scale will be administered on Day 0, Day 7, and Day 14. Additionally, to assess biomarkers, biochemical tests for PCR, calprotectin, and fecal lactoferrin will be conducted. |
Countries
Mexico
Outcome results
None listed