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Postinfectious Irritable Bowel Syndrome and Gelsectan

NCT05045768 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2024-02-28

No results posted yet for this study

Summary

Irritable Bowel Syndrome (IBS) is one of the most common conditions diagnosed in gastroenterology practice. Acute infectious gastroenteritis represents the strongest known risk factor for IBS development; a condition known as post-infection IBS (PI-IBS). PI-IBS patients are more likely than sporadic IBS patients to exhibit a diarrhea-predominant phenotype. The investigators plan to prospectively recruit two groups of patients: patients with diarrhea-predominant post-infectious IBSand patients with diarrhea predominant classical IBS (non PI-IBS) who will be used as controls.

Patients included in the study will receive for 28 days a capsule containing Tamarind seed polysaccharide containing xyloglucan, combined with a pea protein reticulated with grape seed extractand a prebiotic, the xilooligosaccharide (Gelsectan, Devintec Sagl) twice daily.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

(Gelsectan, Devintec Sagl)

Patients included in the study will receive for 28 days a capsule containing Xyloglucan, Pea Protein and Grape Seed Extract and a prebiotic Xylo-oligosaccharide (Gelsectan, Devintec sagl) twice daily.

Sponsors & Collaborators

  • Evangelismos Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-02-26
Completion
2024-02-26

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05045768 on ClinicalTrials.gov