Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

NCT ID: NCT05523427

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-19
• Study Completion Date: 2023-01-06

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.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard treatment of IBS

Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg

They were administered in a single capsule, three time daily before meals.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Probiotics + Standard treatment of IBS

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.

Group Type: EXPERIMENTAL

Two probiotic strains (L. plantarum and L. acidophilus)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Two probiotic strains (L. plantarum and L. acidophilus)

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

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mosul

OTHER

Sponsor Role: lead

Responsible Party

Radhwan Al-Zidan

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Mosul

Mosul, Ninevah, Iraq

Countries

Iraq

Other Identifiers

CCMRE-phA-22-11

Identifier Type: -

Identifier Source: org_study_id