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

Universidad Autonoma de Nuevo Leon

Status: Invitation-only

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome Mixed

Treatments: Dietary Supplement: Ananá

Study type: Interventional

Funder types: Other

Identifiers

NCT07103772

23-FaSPyN-AG-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

Ananá´s Nutraceutical Goup

Experimental group

Description:

47 personas recibirán el tratamiento de 14 días con el suplemento nutracéutico.

Treatment:

Dietary Supplement: Ananá

Ananá´s Placebo Group

Placebo Comparator group

Description:

47 people will recieve the 14 day treatment with the placebo supplement.

Treatment:

Dietary Supplement: Ananá