UnknownNot Applicable

A Bifido Bacteria to Improve Lactose Digestion and Tolerance

United States35 participantsStarted 2022-05-01

Plain-language summary

We want to determine if feeding a bifido bacteria that readily digests lactose and galactooligosacharides improves lactose digestion and tolerance through alteration of the microbiome.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Ability/desire to provide informed consent
✓. Aged 18 to 65 years of age inclusive at screening
✓. Self report of lactose intolerance or lactose maldigestion
✓. Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid®, Dietary Supplements, probiotics) during study involvement
✓. Willing to return for all study visits and complete all study related procedures, including fasting before and during the hydrogen breath tests, and avoiding lactose in their diets (ex. milk, fluid, and soft dairy foods) for Days 1-28 of the study
✓. Able to understand and provide written informed consent in English

Exclusion criteria

✕. Allergic to milk
✕. Currently pregnant
✕. Currently lactating
✕. Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening
✕. Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
✕. History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\]
✕. Past or present : Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.
✕. Active ulcers, or history of severe ulcers

What they're measuring

Bifidus feeding will change lactose digestion

Timeframe: 14 days

Bifidus feeding will change lactose intolerance symptoms

Timeframe: 14 days

Trial details

NCT IDNCT05668468

SponsorPurdue University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

Contact for this trial

Dennis Savaiano, PhD

765 494 8228 savaiano@purdue.edu

View on ClinicalTrials.gov More Lactose Intolerance trials