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Effect of B-GOS on GI Discomfort in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01824667
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Clasado Limited

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: B-GOS Dietary Supplement: Maltodextrin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : February 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: B-GOS
2.75g daily for 4 weeks
Dietary Supplement: B-GOS
Other Name: Bimuno

Placebo Comparator: Maltodextrin
2.75g daily for 4 weeks
Dietary Supplement: Maltodextrin
Other Name: corn syrup




Primary Outcome Measures :
  1. To determine the effect of B-GOS on GI discomfort [ Time Frame: Participants will be followed daily for 6 weeks ]
    questionnaires


Secondary Outcome Measures :
  1. To conduct an assessment of stools [ Time Frame: Participants will be followed daily for 6 weeks. ]
    questionnaires


Other Outcome Measures:
  1. To assess the effect of B-GOS on the quality of life and general well being. [ Time Frame: beginning and end of the study ]
    questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824667


Locations
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United Kingdom
Research Insights Ltd
Oxford, United Kingdom, OX11 9LH
Sponsors and Collaborators
Clasado Limited

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Responsible Party: Clasado Limited
ClinicalTrials.gov Identifier: NCT01824667     History of Changes
Other Study ID Numbers: CLAS/1213
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: April 2013