A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult

This study has been completed.
Sponsor:
Collaborator:
Ganeden Biotech, Inc.
Information provided by:
Miami Research Associates
ClinicalTrials.gov Identifier:
NCT00881322
First received: April 13, 2009
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Abdominal Pain
Abdominal Cramps
Flatulence
Dietary Supplement: BC-130 (Gas Defense)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Miami Research Associates:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BC-130
Active Arm
Dietary Supplement: BC-130 (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.

Other Name: Gas Defense
Placebo Comparator: Sugar Pill
Placebo
Dietary Supplement: Placebo

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


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881322

Locations
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
Dominican Republic
Latin American Research
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Miami Research Associates
Ganeden Biotech, Inc.
Investigators
Principal Investigator: Diane Krieger, MD Medical Director
  More Information

No publications provided by Miami Research Associates

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diane Krieger, MD - Principal Investigator, Miami Research Associates
ClinicalTrials.gov Identifier: NCT00881322     History of Changes
Other Study ID Numbers: GAN-2008
Study First Received: April 13, 2009
Last Updated: September 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colic
Abdominal Pain
Flatulence
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Gastrins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014