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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
Must not have
Active ulcers, or history of severe ulcers
Currently undergoing chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Summary
This trial aims to see if a special type of beneficial bacteria can help people who have trouble digesting lactose. The bacteria, Bifidobacterium adolescentis IVS-1, is given to participants to see if it can improve their ability to digest dairy products and reduce discomfort. The study focuses on people with lactose intolerance and tests how well this bacteria works in their gut.
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.
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.
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.
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I am willing and able to give my consent to participate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active ulcers or a history of severe ulcers.
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I am currently receiving chemotherapy.
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I regularly use antacids or proton pump inhibitors.
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I have diabetes (type 1 or type 2).
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I have been diagnosed with congestive heart failure.
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I do not have HIV, Hepatitis B, or Hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bifidus feeding will change lactose digestion
Bifidus feeding will change lactose intolerance symptoms
Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for lactose intolerance include lactase enzyme supplements, lactose-free diets, and probiotics. Lactase supplements provide the enzyme needed to break down lactose, while lactose-free diets eliminate the source of the problem.
Probiotics, such as bifidobacteria, work by altering the gut microbiome to enhance lactose digestion and improve tolerance. These beneficial bacteria can metabolize lactose, reducing symptoms like bloating, diarrhea, and gas.
This approach is particularly important for lactose intolerance patients as it offers a potential long-term solution by modifying the gut environment to better handle lactose.
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Who is running the clinical trial?
Purdue UniversityLead Sponsor
229 Previous Clinical Trials
72,859 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
Media Library
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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