Non-diarrhea Functional Bowel SymptomsGM-WGTTNCT01004484
Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms
A study testing A probiotic yogurt with inulin and Acidified dairy snack in people with Non-diarrhea Functional Bowel Symptoms, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-diarrhea Functional Bowel Symptoms
- What is being tested?
- A probiotic yogurt with inulin and Acidified dairy snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC-CH Program of Digestive Health
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-diarrhea Functional Bowel Symptoms
- Being tested
- A probiotic yogurt with inulin, Acidified dairy snack
- Keywords
- non-patients, non-diarrhea functional bowel symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A probiotic yogurt with inulinOther
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 snackOther
A 4 oz. cup of acidified dairy snack, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Yogurt with probiotics and inulin | Active comparator | 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). Receives: Other: A probiotic yogurt with inulin |
| Placebo | Placebo comparator | Acidified dairy snack without yogurt cultures, probiotic or inulin. Receives: Other: Acidified dairy snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures will be the whole gut (WGTT) and colonic transit time (CTT) as assessed by SmartPill™
Measured: 10-28 days
Secondary outcomes (1)
Secondary outcome measures (a) Stool frequency (b) Stool consistency (c) Gastric emptying and small bowel transit time
Measured: 10-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-diarrhea Functional Bowel SymptomsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Investigators
- Tamar Ringel-Kulka, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004484
- Sponsor's protocol ID
- 09-0480
- Acronym
- GM-WGTT
- Status last verified
- Dec 2010
- First submitted
- 29 Oct 2009
- Last updated
- 21 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Yogurt Containing Bifidobacterium Lactis (Bb12) in Subjects With Non-Diarrhea Functional Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT01004484
- Acronym / sponsor ID
- GM-WGTT / 09-0480
- Conditions
- Non-diarrhea Functional Bowel Symptoms
- Keywords
- non-patients, non-diarrhea functional bowel symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogurt with probiotics and inulin | Active comparator | Other: A probiotic yogurt with inulinA 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). |
| Placebo | Placebo comparator | Other: Acidified dairy snackAcidified dairy snack without yogurt cultures, probiotic or inulin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A probiotic yogurt with inulinA 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. | Other | Yogurt with probiotics and inulin |
| Acidified dairy snackA 4 oz. cup of acidified dairy snack, once daily. | Other | Placebo |
Primary outcome
The primary outcome measures will be the whole gut (WGTT) and colonic transit time (CTT) as assessed by SmartPill™
Time frame: 10-28 days
1 secondary outcome
Secondary outcome measures (a) Stool frequency (b) Stool consistency (c) Gastric emptying and small bowel transit time
Time frame: 10-28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamar Ringel-Kulka, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A probiotic yogurt with inulin and Acidified dairy snack in people with Non-diarrhea Functional Bowel Symptoms, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures will be the whole gut (WGTT) and colonic transit time (CTT) as assessed by SmartPill™ (time frame: 10-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2010.