Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

Study Overview
=================
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.

Official Title
-----------------
Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial

Conditions
-----------------
Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment of IBS<br>Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals. | |
| Experimental: Probiotics + Standard treatment of IBS<br>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. | Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucus, IBS, IBS-D, Abdominal pain, Abdominal distention, Probiotic, Lactobacilli, L. plantarum, L. acidophilus