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Probiotics and Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lactobacillus delbruekii
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring intestinal microbiota,, probiotics,, quality of life,

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tropical medicine department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1:Probiotic arm

Group 2:Placcebo arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of IBS Symptoms
via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)

Secondary Outcome Measures

Full Information

First Posted
September 27, 2020
Last Updated
October 1, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04572932
Brief Title
Probiotics and Irritable Bowel Syndrome
Official Title
Evaluation of the Use of Probiotics In Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
intestinal microbiota,, probiotics,, quality of life,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1:Probiotic arm
Arm Type
Active Comparator
Arm Description
first group was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily for 4 weeks
Arm Title
Group 2:Placcebo arm
Arm Type
Active Comparator
Arm Description
the second group received only itopridehcl 50mg by the same dose for four weeks.
Intervention Type
Drug
Intervention Name(s)
lactobacillus delbruekii
Other Intervention Name(s)
and lactobacillus fermentum), and itopride hcl
Intervention Description
Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl
Primary Outcome Measure Information:
Title
Change of IBS Symptoms
Description
via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: 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 immuno-compromised patients Refusal to participate in the study
Facility Information:
Facility Name
Tropical medicine department
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
To publish the results of this research . further studies on larger number of patients and for longer durtion as future plan

Learn more about this trial

Probiotics and Irritable Bowel Syndrome

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