Lactulose for Pediatric Obesity

(NMoO Trial)

Overseen By NICOLA SANTORO, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Metformin, GLP-1 analogues

Disqualifiers: Pregnancy, Endocrinopathies, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

55 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking medications that affect insulin resistance, like metformin or GLP-1 analogues, you will need to stop taking them to participate in this trial.

Is lactulose safe for use in children, including those with obesity?

There is limited information on the safety of drugs like lactulose specifically for obese children, as most drug labels do not include dosing or safety guidance for this group. However, lactulose is generally considered safe for use in humans for other conditions, but specific safety data for pediatric obesity is lacking. ^{1 2 3 4 5}

How does the drug Lactulose differ from other treatments for pediatric obesity?

Lactulose is unique in the treatment of pediatric obesity as it is primarily used for conditions like constipation and liver disease, and its use for obesity is novel. Unlike other obesity drugs, which are limited and often have modest effects, Lactulose may offer a different mechanism of action by affecting gut health and metabolism. ^{3 6 7 8 9}

What is the purpose of this trial?

Given the pervasiveness of Pediatric Obesity, it is imperative to understand its pathophysiology and develop alternative strategies to reverse this condition. Herein, investigators propose to elucidate the interaction between colonic fermentation and insulin resistance in modulating metabolism in youth with obesity.

Research Team

NICOLA SANTORO, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for young individuals with obesity, aiming to explore how their metabolism is affected by insulin resistance. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria.

Inclusion Criteria

I am between 15 and 22 years old.

BMI >85th

I am in the middle to late stages of puberty.

Exclusion Criteria

Pregnancy

I have a hormone disorder like Cushing syndrome.

High fibers intake (> 30g/day) as assessed by a 3-day food record.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either remote or control physical exercise interventions to study the effects on insulin resistance and metabolism

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for changes in metabolic markers such as PYY, ghrelin, and gluconeogenesis after treatment

4 weeks

Treatment Details

Interventions

• Lactulose Oral Product

Trial Overview The study investigates the effects of a Lactulose Oral Product on colonic fermentation and its potential role in improving metabolism and reversing insulin resistance among obese youth.

Participant Groups

Group I: Remote physical exercise Experimental Treatment 1 Intervention

Group II: Control physical excercise Active Control 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A comprehensive evaluation of obese children and adolescents should include assessments of weight, body fat, and potential underlying health issues, as well as risk factors for diseases like diabetes and hypertension.

Successful obesity treatment involves setting realistic goals, promoting a balanced low-fat/high-fiber diet, achieving a safe weight loss of 1-2 pounds per week, increasing physical activity, and providing strong parental support along with behavior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of childhood obesity in pediatric practice. Williams, CL., Campanaro, LA., Squillace, M., et al.[2019]

Children with obesity often do not have appropriate drug dosing guidelines, leading to increased risks of adverse events and challenges for healthcare providers in managing their care.

The study emphasizes the need for well-designed pharmacokinetic (PK) trials and collaboration with the FDA to improve drug labeling and dosing information for this vulnerable population, which could significantly enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. Zimmerman, KO., Benjamin, DK., Becker, ML., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Obesity and Pediatric Drug Development. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of obesity in paediatric patients. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Management of childhood obesity in pediatric practice. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Obesity Considerations in Pediatric Drug Development, 2016-2021. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for childhood obesity: present and future prospects. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Medical treatment of weight loss in children and adolescents with obesity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Childhood obesity: A review of current and future management options. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The safety of pharmacologic treatment for pediatric obesity. [2019]