- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004484
Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms (GM-WGTT)
December 17, 2010 updated by: University of North Carolina, Chapel Hill
Physiological Effects of Yogurt Containing Bifidobacterium Lactis (Bb12) in Subjects With Non-Diarrhea Functional Gastrointestinal Symptoms
Hypothesis:
- Daily consumption of yogurt containing probiotic bacteria (Bb12) and inulin will significantly decrease whole gut and intestinal segmental transit time
- The effect of accelerating intestinal transit will be associated with other GI physiology parameters including stool frequency and stool consistency.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In previous preliminary study we have shown that daily consumption of a probiotic yogurt drink containing probiotic bacteria (Bifidobacterium lactis Bb12) and inulin significantly accelerate colonic transit time in non-patients population with functional bowel symptoms.
In this study we investigate the physiologic effect(s) of yogurt with the same bacteria and inulin on gastrointestinal function by assessing its effect on the whole gut and segmental transit time using SmartPill™ - a recently introduced device of measuring intestinal transit time.
The proposed study will provide additional information on the effect on the whole gut transit as well as on other segments of the GI tract (stomach and small bowel).
Assessment of transit time in the proposed study will be done following 10 to 14 days of the probiotic yogurt consumption.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC-CH Program of Digestive Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent.
- 18 - 70 y/o.
- Existing functional GI symptoms for at least two weeks.
- No current prescription treatment of functional GI Symptoms. Over the counter (OTC) medications allowed if still symptomatic despite current OTC therapy.
- Normal colonoscopy within the last 3 years if age >50.
- Normal initial screening evaluation including medical history, physical examination, and laboratory tests (CBC, ESR, blood chemistry including BUN, electrolytes, serum creatinine, bilirubin, ALT, AST, ALP, amylase, lipase, TSH, and routine stool microbiology).
Exclusion Criteria:
- Physician treatment of functional bowel symptoms in the last 10 months.
- Current use of prescription medications for functional bowel symptoms.
- 1 or more bowel movements per day.
- Contraindication to use of Fleets Enema or the balloon expulsion test.
- Severe difficulty with defecation and/or recurrent events of unsuccessful defecation with straining.
- Severe FBD symptoms at baseline.
- Medical diagnosis of FBD
- Daily use of OTC anti-pain, anti-diarrheal or laxative medications.
- Presence of pre-existing serious, unstable medical condition.
- Insulin-dependent Diabetes Mellitus.
- Current diagnosis of major psychiatric disorder or suicide attempt within the last two years.
- History of alcohol or substance abuse within two years.
- Treatment for malignancy other than BCC or SCC within the last 5 years.
- Self-diagnosis of lactase deficiency that explains symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
- Participation in a drug study within the last 21 days.
- Antibiotic treatment or probiotic products consumption during the last 4 weeks.
- Predisposition to infection (i.e. immune system compromised, rheumatic heart disease, artificial valve, history of bacterial endocarditis, active bacterial disease, etc).
- History of gastric bezoar (masses trapped in the gastrointestinal tract).
- Disorders of swallowing and/or severe difficulty swallowing (dysphagia) food or pills.
- Suspected strictures, fistulas, colon cancer or other physiological GI obstruction.
- Allergies to components of the Smart Bar: Granola (Rolled Oats, Evaporated Cane Juice, Expeller Pressed Canola Oil, Defatted Wheat Germ, Oat Flour, Brown Rice Syrup, Molasses, Salt, Natural Flavor, Soy Lecithin), Whey Crisp, Rice Syrup, Corn Syrup, Whey Protein Isolate, Invert Sugar, Puffed Wheat, Apples, Maltodextrin, Sorbitol, Apple Juice Concentrate, Partially Hydrogenated Vegetable Oil (Cottonseed, Soybean), Honey, Natural and Artificial Flavor, Salt, Vanilla.
- Prior GI surgery except for removal of gall bladder or appendix; prior stomach surgery for acid reflux disease (Nissen fundoplication).
- Abdominal surgery within the past 3 months.
- History of inflammatory bowel disease.
- History of inflammation of the lining of the gastrointestinal tract (diverticulitis or diverticulosis), tightening of bowels (diverticular stricture), and other intestinal strictures (per self report).
- Body Mass Index (BMI) > 40
- Female of childbearing age not practicing birth control and/or pregnant or lactating.
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect GI motility.
- Use of medical device such as a pacemaker, infusion pump, or insulin pump.
- Use of following prohibited medications for 1 day prior to the SmartPill ingestion and the day of SmartPill ingestion: (a) Medication to alter gastric pH (Proton Pump Inhibitors); (b) antacids;
- Use of following prohibited medications for 3 days prior to the SmartPill ingestion and the day of SmartPill ingestion (a) Medication to lower stomach; (b) Medication that affect GI motility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Yogurt with probiotics and inulin
A probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving).
|
A 4 oz.
cup with a probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving), once daily.
|
Placebo Comparator: Placebo
Acidified dairy snack without yogurt cultures, probiotic or inulin.
|
A 4 oz.
cup of acidified dairy snack, once daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome measures will be the whole gut (WGTT) and colonic transit time (CTT) as assessed by SmartPill™
Time Frame: 10-28 days
|
10-28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcome measures (a) Stool frequency (b) Stool consistency (c) Gastric emptying and small bowel transit time
Time Frame: 10-28 days
|
10-28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tamar Ringel-Kulka, MD, MPH, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
October 29, 2009
First Submitted That Met QC Criteria
October 29, 2009
First Posted (Estimate)
October 30, 2009
Study Record Updates
Last Update Posted (Estimate)
December 21, 2010
Last Update Submitted That Met QC Criteria
December 17, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 09-0480
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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