Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms
NCT ID: NCT01004484
Last Updated: 2010-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-06-30
2010-04-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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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 probiotic yogurt with inulin
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
Acidified dairy snack without yogurt cultures, probiotic or inulin.
Acidified dairy snack
A 4 oz. cup of acidified dairy snack, once daily.
Interventions
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A probiotic yogurt with inulin
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.
Acidified dairy snack
A 4 oz. cup of acidified dairy snack, once daily.
Eligibility Criteria
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Inclusion Criteria
2. 18 - 70 y/o.
3. Existing functional GI symptoms for at least two weeks.
4. No current prescription treatment of functional GI Symptoms. Over the counter (OTC) medications allowed if still symptomatic despite current OTC therapy.
5. Normal colonoscopy within the last 3 years if age \>50.
6. 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
2. Current use of prescription medications for functional bowel symptoms.
3. 1 or more bowel movements per day.
4. Contraindication to use of Fleets Enema or the balloon expulsion test.
5. Severe difficulty with defecation and/or recurrent events of unsuccessful defecation with straining.
6. Severe FBD symptoms at baseline.
7. Medical diagnosis of FBD
8. Daily use of OTC anti-pain, anti-diarrheal or laxative medications.
9. Presence of pre-existing serious, unstable medical condition.
10. Insulin-dependent Diabetes Mellitus.
11. Current diagnosis of major psychiatric disorder or suicide attempt within the last two years.
12. History of alcohol or substance abuse within two years.
13. Treatment for malignancy other than BCC or SCC within the last 5 years.
14. Self-diagnosis of lactase deficiency that explains symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
15. Participation in a drug study within the last 21 days.
16. Antibiotic treatment or probiotic products consumption during the last 4 weeks.
17. Predisposition to infection (i.e. immune system compromised, rheumatic heart disease, artificial valve, history of bacterial endocarditis, active bacterial disease, etc).
18. History of gastric bezoar (masses trapped in the gastrointestinal tract).
19. Disorders of swallowing and/or severe difficulty swallowing (dysphagia) food or pills.
20. Suspected strictures, fistulas, colon cancer or other physiological GI obstruction.
21. 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.
22. Prior GI surgery except for removal of gall bladder or appendix; prior stomach surgery for acid reflux disease (Nissen fundoplication).
23. Abdominal surgery within the past 3 months.
24. History of inflammatory bowel disease.
25. 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).
26. Body Mass Index (BMI) \> 40
27. Female of childbearing age not practicing birth control and/or pregnant or lactating.
28. Cardiovascular, endocrine, renal, or other chronic disease likely to affect GI motility.
29. Use of medical device such as a pacemaker, infusion pump, or insulin pump.
30. 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;
31. 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
18 Years
70 Years
ALL
No
Sponsors
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General Mills
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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The University of North Carolina at Chapel Hill
Principal Investigators
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Tamar Ringel-Kulka, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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UNC-CH Program of Digestive Health
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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09-0480
Identifier Type: -
Identifier Source: org_study_id