Abdominal PainNCT00881322
A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult
A study testing BC-130 (Gas Defense) in people with Abdominal Pain and Abdominal Cramps, run by Miami Research Associates at 2 sites in 2 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The study will last approximately four weeks, and subjects will be seen at a screening/randomization visit, and two follow-up visits. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain, Abdominal Cramps, Flatulence
- What is being tested?
- BC-130 (Gas Defense)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2008to Sep 2008
- 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
- Subject is 18-75 years of age.
- Subject self-reports at least one of the following symptoms after eating a meal or snack:
- Abdominal pain/cramps
- Distended feeling/bloating
- Flatulence/gas
- Subject is in otherwise general good health as determined by physical exam and medical history.
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- Subject is willing and able to comply with the protocol.
- Female subjects not defined as post-menopausal (excluding hysterectomized and post bilateral tubal ligations) must use a reliable method of birth control as defined within this protocol.
- Subject is able to understand and sign the informed consent (English or Spanish) to participate in the study.
Who cannot join
- Subject has any of the following medical conditions:
- active heart disease
- renal or hepatic impairment/disease
- Type I or II diabetes
- psychiatric disorders (hospitalized within the past one year)
- bipolar disorder
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- Parkinson's disease
- unstable thyroid disease
- immune disorder (such as HIV/AIDS)
- any medical condition deemed exclusionary by the Principal Investigator (PI)
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
- Subject has had any stomach or intestinal surgery (i.e. gastric bypass).
- Subject is currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 30 days prior to screening/enrollment.
- Subject is currently taking or has used in the past 30 days probiotics or prebiotics.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Subject is currently taking any medication deemed exclusionary by PI.
- Subject has a history of or currently has any gastrointestinal disorders or inflammatory bowel conditions such as Crohn's disease, short bowel, or ulcerative colitis. Subjects may not have a diagnosis, be seeing a doctor, or taking prescription medication(s) for Irritable Bowel Syndrome (IBS).
- Subject has constipation defined as less than three spontaneous bowel movements per week.
- Subject is lactose intolerant (self-professed or diagnosed).
- Subject uses any of the following classification of GI medications two or more times per week: anti-spasmodics, motility agents, pro-kinetic agents or laxatives.
- Subject plans to use another over-the-counter gas-relief product daily during the study period. Over-the-counter gas relief products may be used as rescue medication (their use will be captured by the study staff). If a subject is using a fiber supplement prior to starting the study, he/she may continue as long as the frequency and quantity remain stable throughout the study period.
- Subject has an allergy to wheat or fish or any of the other product ingredients (see section 2.5.4).
- Subject has two or more food allergies.
- Subject has a history of drug or alcohol abuse within the past 12 months.
- Subject is deemed by the Investigator as an unsuitable candidate for receipt of an investigational dietary supplement, or unable to be followed up throughout the entire duration of the study.
- Female subject of childbearing potential is unwilling to use an acceptable form of contraceptive device throughout the study period.
- Subject is pregnant, lactating, or planning to become pregnant during the study period.
- Subject is participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment.
- Subject is deemed by the Investigator as an unsuitable candidate for receipt of an investigational dietary supplement, or unable to be followed up throughout the entire duration of the study.
- Subject is unable to comprehend the Informed Consent and research purpose.
- Subject is unable or unwilling to comply with the protocol.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Effects of Gas Defense On Intestinal Gas Symptoms in Otherwise Healthy Adults
This is a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The study will last approximately four weeks, and subjects will be seen at a screening/randomization visit, and two follow-up visits.
Study procedures will include administering questionnaires for assessment of the study product's effect on intestinal gas symptoms and quality of life.
- Conditions
- Abdominal Pain, Abdominal Cramps, Flatulence
- Being tested
- BC-130 (Gas Defense), Placebo
- Medical subject headings
- Abdominal Pain, Colic, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC-130 (Gas Defense)Dietary supplement
Also called Gas Defense
Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish.
PlaceboDietary supplement
Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD\&C yellow #5 Lake, FD\&C blue #1 Lake, FD\&C red #46 Lake and vegetable capsule
| Study group | Role | What they receive |
|---|---|---|
| BC-130 | Experimental | Active Arm Receives: Dietary Supplement: BC-130 (Gas Defense) |
| Sugar Pill | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of daily supplementation with GD as compared to placebo on intestinal gas symptoms as measured by the subscores of the GI Symptom Rating Scale (GSRS) and the subscores of the Severity of Dyspepsia Assessment (SODA).
Measured: 4 weeks
Primary Safety Objective To determine if daily supplementation with GD is safe within the confines of this study as denoted by changes from baseline in blood pressure, heart rate, adverse events, and subjective remarks.
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 posted15 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
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 PainStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami Research Associates
- Sponsor type
- Research network
- Collaborators
- Ganeden Biotech, Inc.
- Investigators
- Diane Krieger, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881322
- Sponsor's protocol ID
- GAN-2008
- Status last verified
- Sep 2009
- First submitted
- 13 Apr 2009
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol. 2009 Nov 18;9:85. doi: 10.1186/1471-230X-9-85.
PubMed 19922649
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Effects of Gas Defense On Intestinal Gas Symptoms in Otherwise Healthy Adults
- ClinicalTrials.gov ID
- NCT00881322
- Acronym / sponsor ID
- GAN-2008
- Conditions
- Abdominal Pain, Abdominal Cramps, Flatulence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Miami Research AssociatesResearch network
- Collaborators
- Ganeden Biotech, Inc.
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Apr 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.
This is a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The study will last approximately four weeks, and subjects will be seen at a screening/randomization visit, and two follow-up visits.
Study procedures will include administering questionnaires for assessment of the study product's effect on intestinal gas symptoms and quality of life.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BC-130 | Experimental | Dietary Supplement: BC-130 (Gas Defense)Active Arm |
| Sugar Pill | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is 18-75 years of age.
- Subject self-reports at least one of the following symptoms after eating a meal or snack:
- Abdominal pain/cramps
- Distended feeling/bloating
- Flatulence/gas
Key exclusion criteria (31 listed)
- Subject has any of the following medical conditions:
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
- Subject has had any stomach or intestinal surgery (i.e. gastric bypass).
- Subject is currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 30 days prior to screening/enrollment.
- Subject is currently taking or has used in the past 30 days probiotics or prebiotics.
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 |
|---|---|---|
| BC-130 (Gas Defense)Also: Gas DefenseProduct Dosing: Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food) Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish. | Dietary supplement | BC-130 |
| PlaceboProduct Dosing: Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food) Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD\&C yellow #5 Lake, FD\&C blue #1 Lake, FD\&C red #46 Lake and vegetable capsule | Dietary supplement | Sugar Pill |
Primary outcome
To determine the effect of daily supplementation with GD as compared to placebo on intestinal gas symptoms as measured by the subscores of the GI Symptom Rating Scale (GSRS) and the subscores of the Severity of Dyspepsia Assessment (SODA).
Time frame: 4 weeks
Primary Safety Objective To determine if daily supplementation with GD is safe within the confines of this study as denoted by changes from baseline in blood pressure, heart rate, adverse events, and subjective remarks.
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 30 Sep 2009.
- Derived from this study: PubMed 19922649Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol. 2009 Nov 18;9:85. doi: 10.1186/1471-230X-9-85.
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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.
Diane Krieger, MD principal investigator
Medical Director
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BC-130 (Gas Defense) in people with Abdominal Pain and Abdominal Cramps, run by Miami Research Associates at 2 sites in 2 countries.
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 9 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 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Dominican Republic. 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?
To determine the effect of daily supplementation with GD as compared to placebo on intestinal gas symptoms as measured by the subscores of the GI Symptom Rating Scale (GSRS) and the subscores of the Severity of Dyspepsia Assessment (SODA). (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT00881322, 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 30 Sep 2009.