Efficacy of Yogurt Containing BB12 in Subjects With GI Symptoms

NCT00618488 | Completed

• 1 other identifier: 06-0922
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if probiotics bacteria, specifically bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).

Conditions

Pain

Keywords

Probiotics; BB12; Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

• The global relief of functional GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.

  March 2008

Secondary Outcomes (1)

• The satisfaction with treatment as assessed by Satisfaction Survey.

  March 2008

Study Arms (2)

1

EXPERIMENTAL

Bifidobacterium lactis

Dietary Supplement: Probiotic BB12 - Bifidobacterium lactis

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Probiotic BB12 - Bifidobacterium lactis DIETARY_SUPPLEMENT

Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks

1

Placebo DIETARY_SUPPLEMENT

Placebo administered once a day for 6 weeks

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 18 - 70 y/o.
• The subject has any functional GI symptoms that are related to IBS, functional diarrhea, functional constipation, or functional bloating according to the Rome II criteria for functional GI disorders. The subject has the above symptoms for at least two weeks (i.e., active symptoms on enrollment). The subject has not been seen by a medical care provider for these symptoms in the 10 months and is not taking prescribed medications for these symptoms. Over the counter (OTC) medications are allowed as long as the subject is still symptomatic despite current OTC therapy.
• For diarrhea we will use the definition of a mean of \>2 bowel movements per day, or a mean score of \> 4 on the Bristol Stool Form Scale per week.
• For constipation we will use the definition of a mean of \<3 bowel movements per week or a need for significant straining for a bowel movement.
• The subject's symptoms are mild to moderate in severity. Symptoms severity will be assessed at baseline and at the end of the 2-weeks screening period to determine eligibility prior randomization. Severity of bowel symptoms will be determined using the Francis Whorwell IBS severity scale: Mild \<175, Moderate 175-300, Severe \>300
• Subject must have had a normal colonoscopy within the last 3 years if age \>50y/o.
• Subjects' initial evaluation at screening visit including medical history, physical examination, and laboratory tests are unrevealing i.e., do not show abnormalities that require further investigation.

You may not qualify if:

• The subject saw a physician for your functional bowel symptoms in the last 10 months
• The subject has taken prescribed medications for your functional bowel symptoms
• The subject has inflammation or structural abnormality of the digestive tract \[e.g. inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU), obstruction, or symptomatic cholelithiasis\].
• The subject has severe FBD symptoms at baseline.
• The subject carries a medical diagnosis of FBD and has seen a medical care provider and take prescribed medications for their GI symptoms. Patients who did not see a medical care provider for these symptoms for more than 10 months and are not taking prescribed medications for their GI symptoms are eligible.
• The subject has a serious, unstable medical condition.
• The subject has insulin-dependent Diabetes Mellitus.
• The subject had a major psychiatric diagnosis or a suicide attempt within the last two years.
• The subject has a history of alcohol or substance abuse within two years.
• The subject has abnormal laboratory results (including ALT or AST \> than 2.5 times normal, serum creatinine \>2.0mg/dl, untreated abnormal TSH value)
• The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
• The subject has been diagnosed with lactase deficiency and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
• The subject has participated in a drug study within the last 21 days.
• The subject received antibiotic treatment or intentionally consumes probiotic products during the last 6 weeks. (If the subject was on antibiotic or probiotics treatment, a washout period of 6 weeks is required).
• The subject had previous significant gastric or intestinal surgery.

Sponsors & Collaborators

• University of North Carolina: lead
• General Mills: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7080, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yehuda Ringel, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 20, 2008

Record last verified: 2008-02

Locations

US (1)