Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating

NCT00618904 | Completed

• 1 other identifier: 04-1704
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.

Conditions

Pain

Keywords

Probiotics; Functional Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the global relief of GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.

Secondary Outcomes (1)

• Assess the improvement of specific functional bowel disorders (FBD) related symptoms and Health Related Quality of Life (HRQOL).

Study Arms (2)

1

EXPERIMENTAL

Probiotic containing Lactobacillus and Bifidobacterium

Dietary Supplement: Probiotics - Lactobacillus and bifidobacterium

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Probiotics - Lactobacillus and bifidobacterium DIETARY_SUPPLEMENT

Probiotics administered bid for 6 weeks.

1

Placebo DIETARY_SUPPLEMENT

Placebo administered bid for 6 weeks.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 18 to 75 years old.
• The subject is an ambulatory outpatient.
• The subject has IBS, or functional diarrhea, or functional bloating according to the Rome II criteria for functional GI disorders.
• The subject has the above symptoms for at least two weeks, despite current therapy. For diarrhea, we will use the definition of a mean of \>2 bowel movements per day, or a mean score of \> 4 on the Bristol Stool Form Scale per week. For bloating we will use the Rome II definition "a feeling of abdominal fullness or bloating".
• Subject must have had a colonoscopy if age \> 50y/o.
• The subject's symptoms are mild to moderate symptoms in severity. Symptoms severity will be assessed at baseline and at the end of the 2-weeks screening period to determine eligibility prior randomization. Severity of bowel symptoms will be determined using the Francis Whorwell IBS severity scale: Mild \<175, Moderate 175-300, Severe \>300

You may not qualify if:

• The subject has inflammation or structural abnormality of the digestive tract (e.g. inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU), obstruction, symptomatic cholelithiasis).
• The subject has severe FBD related symptoms at baseline.
• The subject has a serious, unstable medical condition.
• The subject has insulin-dependent Diabetes Mellitus.
• The subject had a major psychiatric diagnosis or a suicide attempt within the last two years.
• The subject has a history of alcohol or substance abuse within two years.
• The subject has abnormal laboratory results (including ALT or AST \> than 2.5 times normal, serum creatinine \>2.0mg/dl, untreated abnormal TSH value)
• The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
• The subject has been diagnosed with lactase deficiency and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
• The subject has participated in a drug study within the last 21 days.
• The subject received antibiotic treatment during the last 8 weeks. (If the subject was on antibiotic treatment, a washout period of 8 weeks is required).
• The subject had previous significant intestinal surgery.
• The subject is pregnant or lactating, or unwilling to maintain effective contraception during course of study
• The subject is predisposed to infection (i.e. their immune system is compromised, they have rheumatic heart disease, an artificial valve, history of bacterial endocarditis, or an active bacterial disease)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Danisco: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7080, United States

Location

Related Publications (1)

• Ringel-Kulka T, Palsson OS, Maier D, Carroll I, Galanko JA, Leyer G, Ringel Y. Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study. J Clin Gastroenterol. 2011 Jul;45(6):518-25. doi: 10.1097/MCG.0b013e31820ca4d6.

  PMID: 21436726 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yehuda Ringel, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 20, 2008
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

US (1)