Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
IBS, IBS-D, Abdominal pain, Abdominal distention, Probiotic, Lactobacilli, Mucus, L. plantarum, L. acidophilus
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.
Interventions
DIETARY_SUPPLEMENTTwo 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.
Sponsors
University of Mosul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline. | Three months | The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL). |
Countries
Iraq
Outcome results
None listed