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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how lactulose, a sugar-like substance, affects metabolism in young people dealing with obesity. Researchers seek to determine if it can help by interacting with insulin resistance, a condition where the body doesn't use insulin properly. The trial includes two groups: one participating in remote physical exercises and another engaging in different exercises for comparison. Young individuals in puberty with a Body Mass Index (BMI) above the 85th percentile might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding potential new treatments for obesity-related insulin resistance.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lactulose is often used to treat brain issues caused by liver problems. However, clear evidence about its safety and effectiveness in children is lacking. Specific information on the frequency of side effects in children is unavailable, creating uncertainty about its safety for them. Those considering this treatment should discuss any concerns with healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about lactulose as a treatment for pediatric obesity because it offers a unique approach by focusing on gut health. Unlike typical obesity treatments that often involve dietary changes, exercise, or medications that curb appetite, lactulose works as a prebiotic. This means it feeds beneficial gut bacteria, potentially improving metabolism and aiding weight management. Additionally, lactulose is administered orally, making it easy for children to take, which could improve adherence compared to more invasive treatments.

What evidence suggests that this trial's treatments could be effective for pediatric obesity?

Research has shown that lactulose might help manage obesity in children by improving gut health. Lactulose can alter gut bacteria, potentially affecting how the body processes food and controls weight. Although specific research on lactulose for obesity is limited, some studies suggest that gut-focused treatments can aid in weight control. Additionally, lactulose is often safely used in children for issues like constipation, indicating it could be a promising option for further exploration in treating obesity in kids. ^{6 7 8 9 10}

Who Is on the Research Team?

NICOLA SANTORO, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5909170/

Inconsistencies in dosage practice in children with overweight ... This study highlights the shortage of dosing guidelines in overweight/obese children. We found a large interindividual variability in dosage regimens.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667025925000317

Role of oral probiotic supplementation on gut permeability ... Probiotics can reportedly help reduce obesity in children, although their impact may not be immediately evident through changes in BMI (Athiyyah et al., 2024).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3143086/

Constipation in children - PMC - PubMed Central - NIH After 2 months of treatment, nearly 40% of children remained symptomatic; which was improved by improved parental understanding and regular laxatives [43].

4. researchgate.net researchgate.net/publication/372054556_Childhood_Obesity_A_Public_Health_Crisis

(PDF) Childhood Obesity: A Public Health Crisis Children of thin parents may do better in weight control than children of obese parents. Adherence to exercise is likely to be a problem with ...

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.713810/full

Treatment Experience of 210 Pediatric Patients With ... This study aimed to explore the benefits of different therapeutic regimens (non-drug treatment vs. oral lactulose) in patients with PEDUF.

6. medline.com medline.com/media/catalog/Docs/MSDS/MSD_SDSD717474.pdf

Material Safety Data Sheet lactulose solution is administered to a nursing. Pediatrics: Safety and effectiveness in pediatric patients have not been established. 12. ECOLOGICAL ...

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9AKORN_LACTULOSE_SOL_ML.pdf

SDS: Lactulose Solution, USP for Oral Administration Ingestion: If a person vomits place them in the recovery position so that vomit will not reenter the mouth and throat. Rinse mouth with water.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK536930/

Lactulose - StatPearls - NCBI Bookshelf - NIH Lactulose is a versatile pharmaceutical agent helpful in preventing and treating clinical portal-systemic encephalopathy.

9. drugs.com drugs.com/pro/lactulose-oral-solution.html

Lactulose Oral Solution: Package Insert / Prescribing Info Pediatric Use. Safety and effectiveness in pediatric patients have not been established. Adverse Reactions/Side Effects. Precise frequency data ...

10. accessdata.fda.gov accessdata.fda.gov/spl/data/85528d56-e38f-4565-9136-c7639b479634/85528d56-e38f-4565-9136-c7639b479634.xml

85528d56-e38f-4565-9136-c7639b479634.xml ... Safety and effectiveness in pediatric patients have not been established. ... </paragraph> <paragraph>When Lactulose For Oral Solution is dissolved in ...