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This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
Full description
A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study.
Subjectsshall be instructed to visit the facility for the following scheduled visits:
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Inclusion criteria
The subject is an adult male or female aged between 18 to 60 years old.
Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month - over at least 2 months - associated with one or more of the following:
i. Related to defecation ii. A change in frequency of stool iii. A change in form (appearance) of stool iv. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
The subject is having refrigerator at their home for storage of test treatment.
The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
i. Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
ii. Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups, including a placebo group
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Central trial contact
Maheshvari N Patel; Sheetal J Khandwala
Data sourced from clinicaltrials.gov
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