Trials / Enrolling By Invitation
Enrolling By InvitationNCT07103772
Effect of Consuming a Nutraceutical Composition on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome
Effect of Consuming a Nutraceutical Composition Based on Pineapple and Natural Extracts on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- Sponsor
- Universidad Autonoma de Nuevo Leon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Irritable Bowel Syndrome
- Irritable Bowel Syndrome With Diarrhea
- Irritable Bowel Syndrome With Constipation
- Irritable Bowel Syndrome Mixed
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Ananá | 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. |
Timeline
- Start date
- 2024-03-14
- Primary completion
- 2025-03-14
- Completion
- 2026-03-15
- First posted
- 2025-08-05
- Last updated
- 2025-09-02
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT07103772. Inclusion in this directory is not an endorsement.