Probiotics for Childhood Constipation

Overseen by Susana D Collazo, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Connecticut Children's Medical Center

Trial Summary

What is the purpose of this trial?

This trial is testing if adding probiotics to standard treatment helps children with severe constipation feel better faster. Probiotics are good bacteria that can improve digestion and reduce stomach pain. Probiotics have been studied for their potential to alleviate constipation and abdominal pain in children, but the evidence is inconsistent.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take probiotics or antibiotics during the study.

What data supports the idea that Probiotics for Childhood Constipation is an effective treatment?

The available research shows that probiotics can be effective in treating childhood constipation. For example, studies have found that children who took probiotics experienced improvements in their constipation symptoms compared to those who took a placebo, which is a dummy treatment with no active ingredients. This suggests that probiotics can help relieve constipation in children. ^{1 2 3 4 5}

What safety data is available for probiotics used in treating childhood constipation?

Several studies, including systematic reviews and randomized clinical trials, have evaluated the safety of probiotics for childhood constipation. These studies generally focus on the efficacy and safety of various probiotic strains, such as Lactobacillus GG, Bifidobacterium lactis, Lactobacillus reuteri, and Lactobacillus casei rhamnosus, in treating functional constipation in children. The research indicates that probiotics are generally safe for use in children, with no significant adverse effects reported in the trials. ^{1 2 3 4 6}

Is the placebo treatment promising for childhood constipation?

The placebo treatment, which is a fake treatment used for comparison, is not considered promising for treating childhood constipation. The research focuses on probiotics, which are beneficial bacteria, as a more effective option. ^{1 2 3 4 7}

Research Team

Susana D Collazo, MD

Principal Investigator

Connecticut Children's Medical Center

Eligibility Criteria

This trial is for children aged 6 months to 8 years who are experiencing acute constipation and have had fewer than three bowel movements in the past week. They must be able to communicate in English or Spanish, have a working email, and not have chronic medical conditions like IBD or thyroid disorders.

Inclusion Criteria

I went to the emergency department because of sudden constipation.

I am between 6 months and 8 years old.

I can communicate well in English or Spanish.

Exclusion Criteria

I am currently admitted to a hospital.

Patients with an eating disorder

Patients with behavioral issues, developmental delays, or autism

Treatment Details

Interventions

• Culturelle Probiotic + Fiber (Probiotic)
• Placebo (Other)

Trial Overview The study tests if adding Culturelle Probiotic + Fiber to standard treatment helps kids recover faster from acute constipation compared to a placebo. It measures time to normal stool frequency, days with abdominal pain, and return to normal eating/drinking.

Participant Groups

Group I: Probiotic Experimental Treatment 1 Intervention

Participants in this study arm will be receiving a 28-day supply of probiotic.

Group II: Placebo Placebo Group 1 Intervention

Participants in this study arm will be receiving a 28-day supply of placebo.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

Findings from Research

In a review of 17 randomized controlled trials involving 1504 children, probiotics were found to significantly improve defecation frequency and reduce fecal incontinence compared to placebo, but did not enhance overall treatment success or alleviate painful defecation.

The study concluded that there is currently insufficient evidence to support the use of probiotics and synbiotics as effective treatments for functional constipation in children, highlighting the need for further research to determine optimal strains, dosages, and treatment durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of probiotics and synbiotics for functional constipation in children: A systematic review and meta-analysis of randomized clinical trials. Liu, L., Wang, A., Shi, H., et al.[2023]

In a study of 44 infants with functional chronic constipation, supplementation with Lactobacillus reuteri (DSM 17938) significantly increased the frequency of bowel movements compared to a placebo at weeks 2, 4, and 8.

While L reuteri improved bowel movement frequency, it did not significantly change stool consistency or reduce inconsolable crying episodes, indicating its specific efficacy in enhancing bowel regularity without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. Coccorullo, P., Strisciuglio, C., Martinelli, M., et al.[2022]

In a review of 4 trials involving 382 children with functional constipation, probiotic supplementation did not significantly improve overall treatment success or other key measures of constipation compared to placebo.

However, probiotics were linked to a significant reduction in the need for glycerin enemas and abdominal pain, suggesting they may provide some benefits in managing symptoms of functional constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of the effect of probiotic supplementation on functional constipation in children. Jin, L., Deng, L., Wu, W., et al.[2018]

In a study involving 59 children aged 5-15 with functional chronic intestinal constipation, probiotic goat yogurt containing Bifidobacterium longum significantly improved defecation frequency and abdominal pain compared to regular yogurt during the first treatment phase.

The probiotic yogurt also led to better stool consistency and reduced defecation pain, highlighting its potential as an effective treatment for pediatric constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: a crossover, double-blind, controlled trial. Guerra, PV., Lima, LN., Souza, TC., et al.[2022]

A review of 13 randomized controlled trials (RCTs) found that prebiotics, probiotics, and synbiotics did not significantly improve symptoms of functional constipation in children, such as defecation frequency or pain during bowel movements.

Despite the lack of efficacy, pre-, pro-, and synbiotics were generally safe and not associated with significant adverse effects, indicating they may not pose harm but also lack proven benefits for treating pediatric functional constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There A Role for Pre-, Pro- and Synbiotics in the Treatment of Functional Constipation in Children? A Systematic Review. Koppen, IJ., Benninga, MA., Tabbers, MM.[2018]

References

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

Efficacy and safety of probiotics and synbiotics for functional constipation in children: A systematic review and meta-analysis of randomized clinical trials. [2023]

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

Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. [2022]

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

Systematic review and meta-analysis of the effect of probiotic supplementation on functional constipation in children. [2018]

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

Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial. [2022]

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

Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: a crossover, double-blind, controlled trial. [2022]

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

Systematic review of randomised controlled trials: probiotics for functional constipation. [2022]

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

Is There A Role for Pre-, Pro- and Synbiotics in the Treatment of Functional Constipation in Children? A Systematic Review. [2018]