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

NCT00881322 | Completed

• 1 other identifier: GAN-2008
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  4 weeks

Study Arms (2)

BC-130

EXPERIMENTAL

Active Arm

Dietary Supplement: BC-130 (Gas Defense)

Sugar Pill

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

BC-130 (Gas Defense) DIETARY_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) 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.

Also known as: Gas Defense

BC-130

Placebo DIETARY_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

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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 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).

Sponsors & Collaborators

• Miami Research Associates: lead
• Ganeden Biotech, Inc.: collaborator

Study Sites (2)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Latin American Research

Santo Domingo, Dominican Republic

Location

Related Publications (1)

• 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.

  PMID: 19922649 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Colic; Flatulence

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Diane Krieger, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 30, 2009

Record last verified: 2009-09

Locations

DO (1); US (1)