Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

University of Mosul

Status: Completed

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Treatments: Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)

Study type: Interventional

Funder types: Other

Identifiers

NCT05523427

CCMRE-phA-22-11

Details and patient eligibility

About

Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 16 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Standard treatment of IBS

No Intervention group

Description:

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

Probiotics + Standard treatment of IBS

Experimental group

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.

Treatment:

Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)