Effect of Consuming a Nutraceutical Composition on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Mixed Irritable Bowel Syndrome With Constipation Irritable Bowel Syndrome With Diarrhea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ananá

Dietary Supplement

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.

Primary outcomes

Effect of the Consumption of a Nutraceutical Composition on Signs and Symptoms in Adult Patients with Irritable Bowel Syndrome.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

Effect of Consuming a Nutraceutical Composition Based on Pineapple and Natural Extracts on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Aug 5, 2025
Registry last updated: Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed