Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms

Completed · Not applicable · Has a placebo group

Conditions studied: Non-diarrhea Functional Bowel Symptoms

In brief

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.

Key facts

Study ID: NCT01004484
Run by: University of North Carolina, Chapel Hill
People needed: 40
Starts: 2009-06-01
Expected to finish: 2010-04-01
Last updated by the study team: 2010-12-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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).

Where it is running

UNC-CH Program of Digestive Health — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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