Last updated: December 20, 2022
Sponsor: Purdue University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Inflammation
Lactose Intolerance
Treatment
N/AClinical Study ID
NCT05660278
IRB-2022-845
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- • Ability/desire to provide informed consent
- Aged 18 to 65 years of age inclusive at screening
- Current or recent history of intolerance to or avoidance of dairy of at least onemonth duration (by self-report and self-reported symptoms).
- Agrees to refrain from all other treatments and products used for dairyintolerance (e.g., Lactaid® Dietary Supplements) during study involvement
- Willing to return for all study visits and complete all study related procedures
- Able to understand and provide written informed consent in English
Exclusion
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 withabnormal gastrointestinal motility such as; Gastroparesis, amyloidosis,neuromuscular diseases (including Parkinson's disease), collagen vasculardiseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
- History of surgery that alters the normal function of the gastrointestinal tractincluding, but not limited to: gastrointestinal bypass surgery, bariatricsurgery, gastric banding, vagotomy, fundoplication, pyloroplasty [Note: historyof uncomplicated abdominal surgeries such as removal of an appendix more than 12months prior to screening will not be excluded]
- Past or present : Organ transplant, chronic pancreatitis, pancreaticinsufficiency, 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 collectionof 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
- Height: ___ Weight: ___ BMI: ___ o Weighing <16.5 kg and BMI > 35 kg/m2
- Recent bowel preparation for endoscopic or radiologic investigation within fourweeks of screening (e.g., colonoscopy prep)
- Use of concurrent therapy(ies) or other products (e.g., laxatives, stoolsofteners, Pepto Bismol®, Lactaid® Dietary Supplements) used for symptoms ofdairy intolerance within 7 days of screening
- Chronic antacid and/or PPI use
- Recent use of systemic antibiotics defined as use within 30 days prior toscreening
- 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 thecardinal
- symptoms of dairy intolerance (i.e., gas, diarrhea, bloating, cramps, stomachpain)
- 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 studywithin 30 days prior to screening
- Prior enrollment in this study
- Any other conditions/issues noted by the study staff and/or PrincipalInvestigator that would impact participation and/or protocol compliance
Study Design
Total Participants: 35
Study Start date:
January 18, 2022
Estimated Completion Date:
August 31, 2025
Study Description
Connect with a study center
Purdue University
West Lafayette, Indiana 47906
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.