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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

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.

Find a Location

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

Bifidobacterium adolescentis IVS-1 capsule (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05668468 — N/A
Lactose Intolerance Research Study Groups: Control Group, Experimental Group
Lactose Intolerance Clinical Trial 2023: Bifidobacterium adolescentis IVS-1 capsule Highlights & Side Effects. Trial Name: NCT05668468 — N/A
Bifidobacterium adolescentis IVS-1 capsule (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05668468 — N/A
~10 spots leftby Oct 2025