Postinfectious Irritable Bowel Syndrome and Gelsectan

NCT05045768 | Completed Phase 4

• 1 other identifier: 348/28-7-2021
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

irritable bowel syndrome; postinfectious; xyloglycan

Outcome Measures

Primary Outcomes (1)

• Disappearance of diarrhea

  Two or less non-watery stools emissions per day (stool of type 5 or less on the Bristol scale).

  After the end of the 28-day administration of xyloglycan

Study Arms (1)

Postinfectious ibs and diarrhea predominant classical IBS

EXPERIMENTAL

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

Drug: (Gelsectan, Devintec Sagl)

Interventions

(Gelsectan, Devintec Sagl) DRUG

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.

Postinfectious ibs and diarrhea predominant classical IBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diarrhea-predominant post-infectious IBSand patients with diarrhea predominant classical IBS (non PI-IBS) who will be used as controls
• Diagnosis of IBS will be made according to the ROME iV criteria as following:
• Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
• Related to defecation
• Associated with a change in frequency of stool
• Associated with a change in form (appearance) of stool. The above-mentioned criteria have to be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
• Diagnosis of post infectious IBS will be made according to the Rome Foundation Working Team criteria as following:
• Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, with symptom onset at least 6 months before diagnosis, associated with two of the following:
• defecation
• a change in frequency of stool
• a change in form (appearance) of stool Symptom development immediately after resolution of acute infectious gastroenteritis
• Infectious gastroenteritis should be defined by positive stool culture in a symptomatic individual or presence of two of the following acute symptoms (when stool culture not available):
• fever
• vomiting
• diarrhea

You may not qualify if:

• Patients should not meet criteria for IBS before onset of acute illness.
• We will exclude patients who are pregnant, who have an oncology history (since these patients might exhibit diarrhea due to their underlying illness) and patients with alcohol dependence (due to the non-compliance shown by these patients) and patients with known hypersensitivity or allergy to any of the ingredients included in Gelsectan.

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: September 1, 2021
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

GR (1)