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Probiotic
Probiotic for Lactose Intolerance
N/A
Recruiting
Led By Dennis Savaiano, PhD
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 65 years of age inclusive at screening
Ability/desire to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study Summary
This trial will test if a beneficial bacteria can help people better digest lactose and reduce their intolerance to it.
Who is the study for?
This trial is for adults aged 18-65 who self-report lactose intolerance or maldigestion, can avoid lactose and certain treatments during the study, and are willing to complete all procedures. Excluded are those with severe gastrointestinal conditions, recent surgeries affecting digestion, high BMI (>35), active ulcers, pregnancy, chemotherapy patients, and those with immune diseases.Check my eligibility
What is being tested?
The trial tests if a Bifidobacterium adolescentis capsule improves lactose digestion in intolerant individuals compared to a placebo. It aims to see if this probiotic can change the gut microbiome to better handle dairy products.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort such as gas or bloating due to changes in the microbiome as it adapts to the bifido bacteria. However, specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I am willing and able to give my consent to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bifidus feeding will change lactose digestion
Bifidus feeding will change lactose intolerance symptoms
Secondary outcome measures
daily symptoms of lactose intolerance will be minimal following return to normal diet
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental GroupExperimental Treatment1 Intervention
Daily Bifidobacterium adolescentis IVS-1,capsule
Group II: Control GroupPlacebo Group1 Intervention
Daily cellulose capsule
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Who is running the clinical trial?
Purdue UniversityLead Sponsor
227 Previous Clinical Trials
72,709 Total Patients Enrolled
3 Trials studying Lactose Intolerance
80 Patients Enrolled for Lactose Intolerance
Dennis Savaiano, PhDPrincipal InvestigatorPurdue University
4 Previous Clinical Trials
928 Total Patients Enrolled
3 Trials studying Lactose Intolerance
80 Patients Enrolled for Lactose Intolerance
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a high colonic enema in the last 30 days.I have not taken antibiotics in the last 30 days.You have reported that you have trouble digesting lactose or are lactose intolerant.I am between 18 and 65 years old.I am currently receiving chemotherapy.I have active ulcers or a history of severe ulcers.I have a history of digestive system diseases that could affect study results.I don't have any conditions that could confuse my dairy intolerance symptoms.I am willing and able to give my consent to participate.I haven't used products for dairy intolerance symptoms in the last 7 days.I have had surgery that changed how my stomach or intestines work, except for simple surgeries like appendix removal over a year ago.You have used cigarettes, tobacco, or nicotine products within the last 3 months.I am willing to follow the study's diet and visit schedule.You weigh too much for your height.You have had issues with drinking alcohol or using drugs in the past year.I regularly use antacids or proton pump inhibitors.I have diabetes (type 1 or type 2).I have been diagnosed with congestive heart failure.I do not have HIV, Hepatitis B, or Hepatitis C.I had a bowel prep for a procedure like a colonoscopy within the last month.You are allergic to milk.I have a condition like Parkinson's or gastroparesis affecting my stomach's movement.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Experimental Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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