Effect of B-GOS on GI Discomfort in Healthy Adults

Healthy Clinical Trial

Official title:

Double-blind, Placebo Controlled, Randomised, Multicentered, of Parallel Design Study to Determine the Effect of B-GOS on GI Discomfort in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824667
• Other study ID #: CLAS/1213
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2013
• Last updated: November 26, 2013
• Start date: February 2013
• Est. completion date: November 2013

Study information

• Verified date: April 2013
• Source: Clasado Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effects of a new food supplement which is currently available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g. bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms but are otherwise healthy.

About 400 volunteers will take part in this study, which will last 6 weeks (to include 4 weeks treatment and 2 weeks follow up period).

Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and flatulence), in the absence of diseases, are commonly associated with food or drug intake or with alterations of bowel habit and vary between individuals in frequency and severity.

Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in trials with healthy younger and older adults and we have observed a trend towards reducing abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who often experience these symptoms and this is what we will investigate now.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 65 years old.

2. Presence of bloated feeling or experiencing abdominal fullness, with or without visible distention, often in the last 12 months.

3. Ability to communicate well with the investigator and to comply with the requirements of the entire study.

4. Volunteer has given written informed consent to participate and is willing to participate in the entire study.

Exclusion Criteria:

1. History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.

2. Undergone surgical resection of any part of the bowel.

3. History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).

4. Received antibiotics in the previous four weeks.

5. Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.

6. Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous one month, or intention to use such drugs during the course of the study.

7. Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.

8. Regular use of any medication with exception of hormonal replacement therapy and contraception.

9. Women who are pregnant or breast-feeding.

10. Fertile women not practicing a medically-approved method of contraception.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• B-GOS

• Maltodextrin

Locations

Country	Name	City	State
United Kingdom	Research Insights Ltd	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Clasado Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the effect of B-GOS on the quality of life and general well being.	questionnaires	beginning and end of the study	No
Primary	To determine the effect of B-GOS on GI discomfort	questionnaires	Participants will be followed daily for 6 weeks	No
Secondary	To conduct an assessment of stools	questionnaires	Participants will be followed daily for 6 weeks.	No