What side effects are associated with this type of intervention?

Common treatments for lactose intolerance, such as probiotics and prebiotics, generally have a good safety profile with few side effects. Probiotics, including bifidobacteria and lactobacilli, are considered safe for most individuals, with rare cases of mild gastrointestinal symptoms like bloating and gas. Prebiotics, which stimulate beneficial gut bacteria, are also well tolerated, though they may cause similar mild gastrointestinal discomfort in some individuals. Serious adverse effects are uncommon, and both treatments are typically safe for use in healthy individuals.

What prior FDA approvals exist?

The FDA has approved several treatments for lactose intolerance, primarily focusing on enzyme replacement therapies such as lactase supplements, which help break down lactose in dairy products. While there are no specific FDA-approved treatments that use Bifido bacteria to alter the microbiome for improving lactose digestion and tolerance, the use of probiotics and prebiotics has been explored in clinical studies. These studies suggest that certain strains of probiotics, including Bifidobacterium, may help improve lactose digestion by modifying the gut microbiota, although more research is needed to confirm their efficacy and safety for this specific use.

What other types of research exist?

Promising alternatives to Bifido Bacteria for lactose intolerance include Lactobacillus reuteri, which has shown benefits in various gastrointestinal conditions, and synbiotics combining probiotics with prebiotics like galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS). These combinations can enhance the growth of beneficial bacteria and improve lactose digestion. Additionally, enzyme supplements like lactase can be considered, although they are not typically recommended for routine use.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

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

0 / 8Eligibility criteria met

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.