Probiotics for Childhood Constipation

Overseen By Sharon Smith, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Autism, Cancer, Hypothyroidism, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether adding probiotics to the usual treatment can help children with acute constipation recover faster. Researchers aim to determine if probiotics can shorten the time for children to resume normal bowel movements, alleviate stomach pain, and help them return to regular eating and drinking habits sooner. The trial divides participants into two groups: one receives Culturelle Probiotic + Fiber (a probiotic supplement), and the other receives a placebo (a substance with no active medicine). Eligible participants are children who have had fewer than three spontaneous bowel movements in a week, with symptoms lasting less than two months. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding the potential benefits of probiotics in treating childhood constipation.

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.

Will I have to stop taking my current medications?

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

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

Research has shown that probiotics, such as Lactobacillus and Bifidobacterium, are generally safe for children with constipation. These probiotics can enhance treatment effectiveness and help children maintain regular bowel movements. Importantly, no major side effects have been reported in children taking probiotics. In one study, the only side effect observed was mild diarrhea in one child, but this occurred after using a different type of laxative. Overall, probiotics are considered a safe option for children with constipation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for childhood constipation, which often involve laxatives or dietary changes, the probiotic treatment offers a different approach. This treatment uses beneficial bacteria to potentially improve gut health and regularity. Researchers are excited about this option because it targets the digestive system's natural balance, potentially reducing side effects associated with other treatments. Plus, probiotics are generally well-tolerated and could provide a gentler, more sustainable solution for managing constipation in children.

What evidence suggests that adding probiotics could be effective for childhood constipation?

This trial will compare the effects of probiotics and a placebo in treating childhood constipation. Research has shown that probiotics can aid in treating constipation in children. In studies, children who took probiotics experienced more frequent bowel movements and greater treatment success. One study found that probiotics could help children feel better faster by reducing symptoms like stomach pain. Probiotics are usually well tolerated and can work as effectively as other treatments, such as polyethylene glycol, a common laxative. Overall, evidence supports that probiotics can effectively manage constipation in children. ^{1 2 4 5 6}

Who Is on the Research Team?

Susana D Collazo, MD

Principal Investigator

Connecticut Children's Medical Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either a probiotic or placebo for 28 days to assess improvement in constipation symptoms

4 weeks

Daily online journal entries

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up call or visit

What Are the Treatments Tested in This Trial?

Interventions

• Culturelle Probiotic + Fiber
• Placebo

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 94 children under 5 years with functional constipation, Lactobacillus casei rhamnosus Lcr35 did not show a significant improvement in treatment success compared to a placebo, indicating it may not be effective for this condition.

Both groups experienced an increase in defecation frequency over the 4-week trial, but the placebo group had a greater increase, suggesting that Lcr35 alone is not a beneficial treatment for childhood constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial. Wojtyniak, K., Horvath, A., Dziechciarz, P., et al.[2022]

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]

Probiotic supplementation, particularly with strains like Bifidobacterium lactis and Lactobacillus casei, shows a positive effect on defecation frequency and stool consistency in adults with constipation, based on a review of five randomized controlled trials involving 377 subjects.

In children, the strain L. casei rhamnosus Lcr35 demonstrated benefits for constipation, while L. rhamnosus GG did not, indicating that not all probiotic strains are equally effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of randomised controlled trials: probiotics for functional constipation. Chmielewska, A., Szajewska, H.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10502344/

Effect of probiotics intake on constipation in children According to the results, our study revealed that the intake of probiotics in children with FC significantly improved treatment success rate and defecation ...

2. withpower.com withpower.com/trial/phase-constipation-8-2022-c1c04

Probiotics for Childhood Constipation · Info for Participants This trial is testing if adding probiotics to standard treatment helps children with severe constipation feel better faster. Probiotics are good bacteria ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5408016/

Positive Effect of Probiotics on Constipation in Children Conclusion: The present study shows that probiotics increase stool frequency and have beneficial effects in Asian children. However, caution is needed when ...

4. acofp.org acofp.org/docs/default-source/ofp/vol-11-no-5-(2019)-september-october-2019/probiotic-use-in-gastrointestinal-conditions-an-overview-of-efficacy-and-evidence.pdf?sfvrsn=eb54abe8_0

Probiotic Use in Gastrointestinal Conditions Probiotics are effective in increasing stool frequency and are well tolerated although treatment with polyethylene glycol (PEG) may be just as effective. A ...

5. aafp.org aafp.org/pubs/afp/issues/2017/0801/p170.html

Probiotics for Gastrointestinal Conditions: A Summary of ... Constipation. Probiotics are effective for children and adults with constipation. Patients should start probiotics at the onset of symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4356179/

Constipation in children: fibre and probiotics - PMC The RCT reported no adverse effects associated with probiotics, but reported one case of mild diarrhoea in a child receiving osmotic laxatives. Comment. The ...