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Observational study to find out efficacy and safety of Bifidobacterium longum W11 plus Fructooligosaccharide combination in patients with irritable bowel syndrome

Not Applicable
Conditions
Health Condition 1: K519- Ulcerative colitis, unspecified
Registration Number
CTRI/2024/07/070510
Lead Sponsor
Abbott India Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients of either sex, aged between 18 and 60 years

OPD Patients with confirmed diagnosis of IBS with any of the three subtypes (viz IBS D/IBS C/IBS M)

Patients with no improvement in symptoms despite treatment with antispasmodics

Exclusion Criteria

Patients will be excluded if they have severe respiratory insufficiency organic brain damage sleep apnea syndrome severe acute or chronic

hepatic insufficiency (risk of occurrence of encephalopathy) myasthenia gravis chronic psychosis major depressive episodes

phobic or obsessional states or dementia

Patients with other pre-existing GI disorders GI surgery abnormal upper and lower GI endoscopy finding family history of colon cancer or inflammatory bowel disease symptoms that discriminate lower GI organic diseases from IBS such as blood in stool nighttime symptoms

that cause sleep disturbance unintentional weight loss or change in typical IBS symptoms such as new and/or different pain and alcohol or drug-dependency

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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