Abdominal DiscomfortNCT01099696
Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating
A study testing B. infantis 35624 in people with Abdominal Discomfort and Bloating, run by Procter and Gamble at 10 sites in United States.
Trial summary
This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Discomfort, Bloating
- What is being tested?
- B. infantis 35624
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2010to Oct 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men and non-pregnant, non-lactating women aged 18 to 75 years of age;
- Body Mass Index (BMI) < or = 40;
- if female, postmenopausal or using adequate contraception
- if over 50 years of age, have had a colonoscopy performed in the previous 5 years with findings that are normal for this population
- be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria during the study and be willing to refrain from taking any medications or preparations that treat lower digestive upsets
- have experienced abdominal discomfort and bloating at least twice a week, on average, over the last 3 months.
Who cannot join
- have been under a physician's care for functional bowel disorders within the past year or have taken prescription medication for functional bowel disorders within the past year;
- have alarm symptoms suggestive of an underlying disease;
- have prior GI surgery (appendectomy and hernia repair are not excluded and cholecystectomy at least 3 years ago is not excluded);
- have a significant acute or chronic coexisting illness or condition;
- have used systemic steroidal agents within the last 30 days;
- have used oral or systemic antibiotics within the last 30 days;
- have used probiotics at least 3 times a week within the last 30 days;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Chapel Hill, North Carolina, 27999
Research Site
Charlottesville, Virginia, 22911
Research Site
Chevy Chase, Maryland, 20815
Research Site
Chicago, Illinois, 60610
Research Site
Cincinnati, Ohio, 45249
Research Site
Greensboro, North Carolina, 27403
Research Site
Greer, South Carolina, 29651
Research Site
Indianapolis, Indiana, 46240
Research Site
Nashville, Tennessee, 37205
Research Site
Rockford, Illinois, 61107
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Benefit of a Probiotic (Bifidobacterium Infantis 35624) in Healthy Subjects With a History of Abdominal Discomfort and Bloating
This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
Read the detailed description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
- Conditions
- Abdominal Discomfort, Bloating
- Being tested
- B. infantis 35624, placebo
- Keywords
- abdominal discomfort and bloating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantis 35624Dietary supplement
- infantis 35624 in white capsules
placeboDietary supplement
white placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| B. infantis 35624 | Experimental | B. infantis 35624 in white capsules Receives: Dietary Supplement: B. infantis 35624 |
| placebo | Placebo comparator | white placebo capsules (inert) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in abdominal discomfort and bloating
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal DiscomfortStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Brum, MD, Study director, P&G
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099696
- Sponsor's protocol ID
- 2009120
- Status last verified
- Dec 2012
- First submitted
- 6 Apr 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017 Jan;112(1):145-151. doi: 10.1038/ajg.2016.511. Epub 2016 Nov 15.
PubMed 27845337
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Benefit of a Probiotic (Bifidobacterium Infantis 35624) in Healthy Subjects With a History of Abdominal Discomfort and Bloating
- ClinicalTrials.gov ID
- NCT01099696
- Acronym / sponsor ID
- 2009120
- Conditions
- Abdominal Discomfort, Bloating
- Keywords
- abdominal discomfort and bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Apr 2010 (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.
This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
Detailed description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B. infantis 35624 | Experimental | Dietary Supplement: B. infantis 35624B. infantis 35624 in white capsules |
| placebo | Placebo comparator | Dietary Supplement: placebowhite placebo capsules (inert) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy men and non-pregnant, non-lactating women aged 18 to 75 years of age;
- Body Mass Index (BMI) < or = 40;
- if female, postmenopausal or using adequate contraception
- if over 50 years of age, have had a colonoscopy performed in the previous 5 years with findings that are normal for this population
- be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria during the study and be willing to refrain from taking any medications or preparations that treat lower digestive upsets
Key exclusion criteria (7 listed)
- have been under a physician's care for functional bowel disorders within the past year or have taken prescription medication for functional bowel disorders within the past year;
- have alarm symptoms suggestive of an underlying disease;
- have prior GI surgery (appendectomy and hernia repair are not excluded and cholecystectomy at least 3 years ago is not excluded);
- have a significant acute or chronic coexisting illness or condition;
- have used systemic steroidal agents within the last 30 days;
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 |
|---|---|---|
| B. infantis 35624B. infantis 35624 in white capsules | Dietary supplement | B. infantis 35624 |
| placebowhite placebo capsules | Dietary supplement | placebo |
Primary outcome
The change in abdominal discomfort and bloating
Time frame: 4 weeks
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 20 Dec 2012.
- Derived from this study: PubMed 27845337Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017 Jan;112(1):145-151. doi: 10.1038/ajg.2016.511. Epub 2016 Nov 15.
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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.
Jose Brum, MD study director
P&G
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. infantis 35624 in people with Abdominal Discomfort and Bloating, run by Procter and Gamble at 10 sites 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 7 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 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 change in abdominal discomfort and bloating (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01099696, which also lists 1 linked publication.
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 20 Dec 2012; AzTrials last refreshed its copy on 31 Oct 2026.