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Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Two probiotic strains (L. plantarum and L. acidophilus)
Sponsored by
University of Mosul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, IBS-D, Abdominal pain, Abdominal distention, Probiotic, Lactobacilli, Mucus, L. plantarum, L. acidophilus

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 16-55
  2. Both genders
  3. Patients diagnosed clinically with IBS based on Rome's criteria
  4. IBS-Diarrhea only with pain & distention
  5. Duration of symptoms 6 months

Exclusion Criteria:

  1. Age > 55
  2. Celiac disease
  3. Inflammatory bowel disease (ulcerative colitis & Crohn's)
  4. Thyroid disease
  5. Colonic CA
  6. Lactose intolerance
  7. Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
  8. Preexisting use of antibiotics in the previous 3 months.
  9. Preexisting systemic diseases

Sites / Locations

  • University of Mosul

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard treatment of IBS

Probiotics + Standard treatment of IBS

Arm Description

Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals.

A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.

Outcomes

Primary Outcome Measures

The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.
The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).

Secondary Outcome Measures

Full Information

First Posted
August 29, 2022
Last Updated
January 14, 2023
Sponsor
University of Mosul
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1. Study Identification

Unique Protocol Identification Number
NCT05523427
Brief Title
Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome
Official Title
Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS
Detailed Description
Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea
Keywords
IBS, IBS-D, Abdominal pain, Abdominal distention, Probiotic, Lactobacilli, Mucus, L. plantarum, L. acidophilus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment of IBS
Arm Type
No Intervention
Arm Description
Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals.
Arm Title
Probiotics + Standard treatment of IBS
Arm Type
Experimental
Arm Description
A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.
Intervention Type
Dietary Supplement
Intervention Name(s)
Two probiotic strains (L. plantarum and L. acidophilus)
Intervention Description
A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.
Primary Outcome Measure Information:
Title
The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.
Description
The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 16-55 Both genders Patients diagnosed clinically with IBS based on Rome's criteria IBS-Diarrhea only with pain & distention Duration of symptoms 6 months Exclusion Criteria: Age > 55 Celiac disease Inflammatory bowel disease (ulcerative colitis & Crohn's) Thyroid disease Colonic CA Lactose intolerance Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy) Preexisting use of antibiotics in the previous 3 months. Preexisting systemic diseases
Facility Information:
Facility Name
University of Mosul
City
Mosul
State/Province
Ninevah
ZIP/Postal Code
41001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

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