Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating

NCT01064661 | Completed

• 1 other identifier: 09-0337
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

We are conducting a study to learn if probiotics, which are live bacteria found in food like yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this study will take probiotic pills to see if this affects the expression of certain pain receptors in the intestines that relate to pain sensation. Biopsies will be taken from the colon before subjects take the probiotic pills. Subjects will then be given one of two different types of probiotic pills to take for 3-4 weeks. After taking the supplements, more biopsies will be collected to see if any changes have taken places. This study requires one screening visit and two clinic visits to UNC hospital. Subjects will also complete daily diary cards for 2 weeks during the study to record their symptoms and also collect 2 stool samples.

Conditions

Abdominal Pain; Abdominal Discomfort; Bloating; Functional Bowel Disorders

Keywords

Probiotics; abdominal pain; abdominal discomfort; bloating; Functional Bowel Disorders

Outcome Measures

Primary Outcomes (1)

• Investigate/compare the effect of the probiotic bacteria L-NCFM alone or in combination with B-LBi07 on expression of intestinal mucosal receptors involved in transmission of nociceptive information.

  21-28 days

Study Arms (2)

Blend probiotic of L-NCFM and B-LBi07

ACTIVE COMPARATOR

Blend probiotic pills of L-NCFM and B-LBi07 BID (2x10\^10 cfu total bacteria per day)

Dietary Supplement: Blend probiotic arm of L-NCFM and B-LBi07

Single probiotic of L-NCFM alone

ACTIVE COMPARATOR

Single probiotic pills of L-NCFM alone BID (2x10\^10 cfu total bacteria per day)

Dietary Supplement: Single probiotic arm of L-NCFM alone

Interventions

Single probiotic arm of L-NCFM alone DIETARY_SUPPLEMENT

Single probiotic of L-NCFM alone pills BID (2x10\^10 cfu total bacteria per day)

Also known as: Lactobacillus Acidophilus NCFM

Single probiotic of L-NCFM alone

Blend probiotic arm of L-NCFM and B-LBi07 DIETARY_SUPPLEMENT

Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10\^10 cfu total bacteria per day)

Also known as: Lactobacillus Acidophilus NCFM, Bifidobacterium Lactids - LBi07

Blend probiotic of L-NCFM and B-LBi07

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent has been signed.
• The subject is a female.
• The subject is 18 - 70 years old.
• Active symptoms of abdominal pain or discomfort. Other functional bowel disorders including IBS, functional abdominal pain, and functional bloating are also allowed. For all functional bowel disorders we will use the definition provided by the Rome III criteria.
• The subject's abdominal pain is of mild to moderate in severity. Severity of abdominal pain will also be determined using 10 point likert scale.
• Subjects \> 50 years old must have had a screening colonoscopy with a normal report in the past 5 years - per subject report at time of phone screen. Removal of polyps and hemorrhoids are acceptable.

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, or symptomatic cholelithiasis.
• The subject has severe abdominal pain symptoms at baseline.
• The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced 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 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 had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery).
• Subject is pregnant or lactating, or planning to become pregnant. (A urine pregnancy test will be performed on female subjects prior to the flexible sigmoidoscopy procedure. Acceptable forms of birth control include oral contraceptives, double barrier method, and IUD cover and must be practiced from the time of enrollment until the time of release from the 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)
• The subject received antibiotic treatment or was intentionally consuming probiotic supplementation on a daily basis during the last 4 weeks. If a subject uses antibiotics or probiotics, a 4 weeks washout period is required prior to enrollment.
• The subject has taken medication for pain relief or anti-inflammatory medications (e.g., aspirin, NSAID, or steroids) in the last 10 days. If a subject uses pain medication or anti-inflammatory medications, a 10 days washout period is required prior to enrollment.

Sponsors & Collaborators

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

Related Publications (2)

• Rousseaux C, Thuru X, Gelot A, Barnich N, Neut C, Dubuquoy L, Dubuquoy C, Merour E, Geboes K, Chamaillard M, Ouwehand A, Leyer G, Carcano D, Colombel JF, Ardid D, Desreumaux P. Lactobacillus acidophilus modulates intestinal pain and induces opioid and cannabinoid receptors. Nat Med. 2007 Jan;13(1):35-7. doi: 10.1038/nm1521. Epub 2006 Dec 10.

  PMID: 17159985 BACKGROUND

• Ringel-Kulka T, Goldsmith JR, Carroll IM, Barros SP, Palsson O, Jobin C, Ringel Y. Lactobacillus acidophilus NCFM affects colonic mucosal opioid receptor expression in patients with functional abdominal pain - a randomised clinical study. Aliment Pharmacol Ther. 2014 Jul;40(2):200-7. doi: 10.1111/apt.12800. Epub 2014 May 22.

  PMID: 24853043 DERIVED

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Yehuda Ringel, MD

  UNC Dept. Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-12