Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome
Conditions
Interventions
IBS-C group:subjects will receive relevant tests and examinations of the health situation, psychological status (depression and anxiety assessment), symptom severity and the composition of gut microbi
Pain-FC group:subjects will receive relevant tests and examinations of the health situation, psychological status (depression and anxiety assessment), symptom severity and the composition of gut micro
Non-Pain-FC group:subjects will receive relevant tests and examinations of the health situation, psychological status (depression and anxiety assessment), symptom severity and the composition of gut m
Healthy subjects:subjects will receive relevant tests and examinations of the health situation, psychological status (depression and anxiety assessment), symptom severity and the composition of gut mi
Sponsors
Hong Kong Baptist University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All participants: 1. Aged between 18 and 65 (inclusive); 2. Understand and be able to follow written and oral instructions in Chinese; 3. Provide informed consent; NP-FC group only: 1. Clinical diagnosis of FC based on the ROME IV criteria; 2. No abdominal pain in the past 3 months OR have abdominal pain = 3.0 on a 0 to 10 point scale; IBS-C group only: 1. Clinical diagnosis of IBS-C based on the ROME IV criteria; Healthy controls only: 1. No clinical diagnosis of IBS-C or FC based on the ROME IV criteria.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of inflammatory bowel disease, celiac disease or microscopic colitis; 2. Clinically significant laboratory or imaging findings; 3. Abnormal colonoscopy and biopsy pathology report; 4. Use of medications and/or supplements that may confound the study outcomes (including but not limited to antibiotics, steroid, analgesic drug, neuromodulator, prebiotics, symbiotics, or probiotics); 5. Frequent alcohol consumption ( >= 3 times per week ); 6. At risk of excessive bleeding, e.g. due to medications (only for those who will undergo endoscopy in this study); 7. Abdominal surgeries within the past year (excluding laparoscopic appendectomy); 8. Pregnancy, breastfeeding or plan to become pregnant within the study timeframe; 9. Severe depression and/or anxiety (Zung Self-rating Depression Scale (SDS)>= 70 and/or Zung Self-rating Anxiety Scale (SAS) >= 60); 10. Vulnerable adults (i.e. mentally or physically disabled to take care of himself/herself); 11. Any disease(s), condition(s) or habit(s) deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research, at the discretion of the investigators; 12. Any disease(s), condition(s) or habit(s) deemed by the investigators that would compromise the individuals ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigato.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota structure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal pain intensity and frequency;Complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs) frequency;Score of questionnaires;Colonic transit time;Glucose breath test: hydrogen and methane concentrations;Three-day food record; | — |
Countries
China
Contacts
Public ContactZhaoxiang Bian
Hong Kong Baptist University
Outcome results
None listed