Probiotics and Irritable Bowel Syndrome

NCT ID: NCT04572932

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-02-29

Brief Summary

This clinical trial was conducted on 90 IBS patients, who fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation) in Egyptair hospital outpatient clinic, Cairo, Egypt between May and December 2019. Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.

Detailed Description

The study includes 90 patients assigned into2 equal groups the first was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily, while the second group receivedonly itopridehcl 50mg by the same dose for four weeks.All patients fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation). Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.

Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding), Known inflammatory bowel disease or celiac disease patients, patients above 50 years of age and immuno-compromised patients were excluded from the study.

The included patients aged from 18 to 50 years fulfilling Rome IV criteria for diagnosis of IBS:Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool).Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire.

All patients were subjected to initial evaluation byfull history taking, questionnaires for (IBS diagnostic questionnaire, IBS-SSSand QOL -IBS survey), clinical examination, investigations (including CBC, ESR, CRP, random sugar, HbA1c, thyroid profile and stool analysis) and radiological assessment bypelvi-abdominal ultrasound to exclude any organic cause..Group one(45 patients) was prescribed probiotic (lactobacillus delbruekii and l. fermentum) 10billion colony forming units and itopride 50mg three times daily for four weeks while group two was prescribed only itopride 50mg three times daily for four weeks.Then reassessment of the questionnaires was done after 4 weeks of treatment for comparison

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1:Probiotic arm

first group was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily for 4 weeks

Group Type: ACTIVE_COMPARATOR

lactobacillus delbruekii

Intervention Type: DRUG

Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl

Group 2:Placcebo arm

the second group received only itopridehcl 50mg by the same dose for four weeks.

Group Type: ACTIVE_COMPARATOR

lactobacillus delbruekii

Intervention Type: DRUG

Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl

Interventions

lactobacillus delbruekii

Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl

Intervention Type: DRUG

Other Intervention Names

and lactobacillus fermentum); and itopride hcl

Eligibility Criteria

Inclusion Criteria

1-Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)].

Exclusion Criteria

1. Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding),

2. Known inflammatory bowel disease or celiac disease patients,

3. patients above 50 years of age

4. immuno-compromised patients

5. Refusal to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Iman Fawzy Montasser

Associate Professor of Tropical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tropical medicine department

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Irritable Bowel Syndrome

Identifier Type: -

Identifier Source: org_study_id