A Bifido Bacteria to Improve Lactose Digestion and Tolerance
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Lactose Intolerance
In brief
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.
Key facts
- Study ID
- NCT05668468
- Run by
- Purdue University
- People needed
- 35
- Starts
- 2022-05-01
- Expected to finish
- 2024-05-01
- Last updated by the study team
- 2022-12-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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
- Diabetes mellitus (type 1 and type 2)
- Congestive Heart Failure (CHF)
- Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- BMI > 35 kg/m2
- Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep)
- Use of concurrent therapy(ies) or other products (e.g., laxatives, stool softeners, Pepto Bismol®,Lactaid® Dietary Supplements, probiotics) used for symptoms of dairy intolerance within 7 days of screening
- Chronic antacid and/or PPI use
- Recent use of systemic antibiotics defined as use within 30 days prior to screening
- Recent high colonic enema, defined as use within 30 days prior to screening
- Any concurrent disease or symptoms which may interfere with the assessment of the cardinal symptoms of dairy intolerance (i.e., gas, diarrhea, bloating, cramps /stomach pain, fecal urgency)
- History of ethanol (alcohol) and/or drug abuse in the past 12 months
- Currently undergoing chemotherapy
- Use of any investigational drug or participation in any investigational study within 30 days prior to screening
- Prior enrollment in this study
- Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance
Where it is running
- Purdue University — West Lafayette, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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