A Bifido Bacteria to Improve Lactose Digestion and Tolerance

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.

Inclusion Criteria:Ability/desire to provide informed consentAged 18 to 65 years of age inclusive at screeningSelf report of lactose intolerance or lactose maldigestionAgrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid®, Dietary Supplements, probiotics) during study involvementWilling 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 studyAble to understand and provide written informed consent in EnglishExclusion Criteria:Allergic to milkCurrently pregnantCurrently lactatingCigarette smoking or other use of tobacco or nicotine containing products within 3 months of screeningDiagnosed 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 hypothyroidismHistory 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 ulcersDiabetes mellitus (type 1 and type 2)Congestive Heart Failure (CHF)Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis CBMI > 35 kg/m2Recent 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 screeningChronic antacid and/or PPI useRecent use of systemic antibiotics defined as use within 30 days prior to screeningRecent high colonic enema, defined as use within 30 days prior to screeningAny 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 monthsCurrently undergoing chemotherapyUse of any investigational drug or participation in any investigational study within 30 days prior to screeningPrior enrollment in this studyAny other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance