Probiotics for treatment of chronic constipation in children

Chris Wallace, Vassiliki Sinopoulou, Morris Gordon, Anthony K Akobeng, Alejandro Llanos-Chea, Gregory Hungria, Liz Febo-Rodriguez, Amanda Fifi, Lilibet Fernandez Valdes, Amber Langshaw, Miguel Saps, Chris Wallace, Vassiliki Sinopoulou, Morris Gordon, Anthony K Akobeng, Alejandro Llanos-Chea, Gregory Hungria, Liz Febo-Rodriguez, Amanda Fifi, Lilibet Fernandez Valdes, Amber Langshaw, Miguel Saps

Abstract

Background: Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.

Objectives: To evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.

Search methods: On 28 June 2021, we searched CENTRAL, MEDLINE, Embase, CINAHL, AMED, WHO ICTR, and ClinicalTrials.gov, with no language, date, publication status, or document type limitations.

Selection criteria: We included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 14 studies (1127 randomised participants): 12 studies assessed probiotics in the treatment of functional constipation, whilst two studies investigated synbiotic preparations. Three studies compared probiotics to placebo in relation to the frequency of defecation at study end, but we did not pool them as there was very significant unexplained heterogeneity. Four studies compared probiotics to placebo in relation to treatment success. There may be no difference in global improvement/treatment success (RR 1.29, 95% CI 0.73 to 2.26; 313 participants; low-certainty evidence). Five studies compared probiotics to placebo in relation to withdrawals due to adverse events, with the pooled effect suggesting there may be no difference (RR 0.64, 95% CI 0.21 to 1.95; 357 participants; low-certainty evidence). The pooled estimate from three studies that compared probiotics plus an osmotic laxative to osmotic laxative alone found there may be no difference in frequency of defecation (MD -0.01, 95% CI -0.57 to 0.56; 268 participants; low-certainty evidence). Two studies compared probiotics plus an osmotic laxative to osmotic laxative alone in relation to global improvement/treatment success, and found there may be no difference between the treatments (RR 0.95, 95% CI 0.79 to 1.15; 139 participants; low-certainty evidence). Three studies compared probiotics plus osmotic laxative to osmotic laxative alone in relation to withdrawals due to adverse events, but it is unclear if there is a difference between them (RR 2.86, 95% CI 0.12 to 68.35; 268 participants; very low-certainty evidence). Two studies compared probiotics versus magnesium oxide. It is unclear if there is a difference in frequency of defecation (MD 0.28, 95% CI -0.58 to 1.14; 36 participants), treatment success (RR 1.08, 95% CI 0.74 to 1.57; 36 participants) or withdrawals due to adverse events (RR 0.50, 95% CI 0.05 to 5.04; 77 participants). The certainty of the evidence is very low for these outcomes. One study assessed the role of a synbiotic preparation in comparison to placebo. There may be higher treatment success in favour of synbiotics compared to placebo (RR 2.32, 95% CI 1.54 to 3.47; 155 participants; low-certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group. One study assessed a synbiotic plus paraffin compared to paraffin alone. It is uncertain if there is a difference in frequency of defecation (MD 0.74, 95% CI -0.96, 2.44; 66 participants; very low-certainty evidence), or treatment success (RR 0.91, 95% CI 0.71 to 1.17; 66 participants; very low-certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group. One study compared a synbiotic preparation to paraffin. It is uncertain if there is a difference in frequency of defecation (MD -1.53, 95% CI -3.00, -0.06; 60 participants; very low-certainty evidence) or in treatment success (RR 0.86, 95% CI 0.65, 1.13; 60 participants; very low-certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group. All secondary outcomes were either not reported or reported in a way that did not allow for analysis.

Authors' conclusions: There is insufficient evidence to conclude whether probiotics are efficacious in successfully treating chronic constipation without a physical explanation in children or changing the frequency of defecation, or whether there is a difference in withdrawals due to adverse events when compared with placebo. There is limited evidence from one study to suggest a synbiotic preparation may be more likely than placebo to lead to treatment success, with no difference in withdrawals due to adverse events. There is insufficient evidence to draw efficacy or safety conclusions about the use of probiotics in combination with or in comparison to any of the other interventions reported. The majority of the studies that presented data on serious adverse events reported that no events occurred. Two studies did not report this outcome. Future studies are needed to confirm efficacy, but the research community requires guidance on the best context for probiotics in such studies, considering where they should be best considered in a potential treatment hierarchy and should align with core outcome sets to support future interpretation of findings.

Conflict of interest statement

KCW has none to declare.

VS has none to declare.

MG ‐ Since January 2019, I have received travel fees to attend international scientific and training meetings from two Pharma companies. These grants included no honoraria, inducement, advisory role or any other relationship and were restricted to the travel and meeting related costs of attending such meetings. This was Digestive Diseases Week May 2019 from companies including Biogaia (2019) and Tillots (2019). Neither of these companies have had any involvement in any works completed by me and I have never had any payments for any other activities for them, as confirmed below. From this date onwards, I have made a personal undertaking to take no further funds from any pharmaceutical or formula company in any form for travel or other related activities. This is to lift the limitations such funding has on my ability to act as a first and corresponding author on reviews, in line with the Cochrane policies on such matters, and is reported in line with these policies. These current declarations will expire in May 2022 and this statement will be updated regularly to reflect this.

AKA has none to declare.

ALC has none to declare.

GH has none to declare.

LFR has none to declare.

AF acted as a consultant for QOL Medical 2018 to 2019.

LFV has none to declare.

AL has none to declare.

MS has received honoraria from the following companies in the last three years: IHS (Innovative Health Solutions): Advisory Panel; QOL Medical: Pediatric Advisory Panel; IQVIA: Consultant; Sucampo: Consultant. None of these companies produce any of the interventions or comparators studied in this review.

All author team members who are Editors with Cochrane Gut had no involvement in the editorial process

Figures

**1.1. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 1: Global improvement or treatment success, as defined by primary studies

**1.2. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 2: Global improvement or treatment success, as defined by primary studies (sensitivity analysis fixed‐effect model)

**1.3. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 3: Withdrawals due to adverse events

**1.4. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 4: Withdrawals due to adverse events (sensitivity analysis fixed‐effect model)

**1.5. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 5: Faecal incontinence, or encopresis, measured at end of study (continuous data)

**1.6. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 6: Faecal incontinence, or encopresis, measured at end of study (dichotomous data)

**1.7. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 7: Need for additional therapies during the study period

**1.8. Analysis**
Comparison 1: Probiotics vs placebo, Outcome 8: Total adverse events

**2.1. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 1: Frequency of defecation (number of stools/week at end of study)

**2.2. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 2: Frequency of defecation (number of stools/week at end of study) (sensitivity analysis fixed‐effect model)

**2.3. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 3: Global improvement or treatment success, as defined by primary studies

**2.4. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 4: Global improvement or treatment success, as defined by primary studies (sensitivity analysis fixed‐effect model)

**2.5. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 5: Withdrawal due to adverse events

**2.6. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 6: Withdrawal due to adverse events (sensitivity analysis fixed‐effect model)

**2.7. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 7: Faecal incontinence, or encopresis, measured at end of study (continuous)

**2.8. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 8: Faecal incontinence, or encopresis, measured at end of study (dichotomous)

**2.9. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 9: Need for additional therapies during the study period

**2.10. Analysis**
Comparison 2: Probiotics and osmotic laxative vs osmotic laxative, Outcome 10: Total adverse events

**3.1. Analysis**
Comparison 3: Probiotics vs magnesium oxide, Outcome 1: Frequency of defecation (number of stools/week at end of study)

**3.2. Analysis**
Comparison 3: Probiotics vs magnesium oxide, Outcome 2: Global improvement or treatment success, as defined by primary studies

**3.3. Analysis**
Comparison 3: Probiotics vs magnesium oxide, Outcome 3: Withdrawals due to adverse events

**3.4. Analysis**
Comparison 3: Probiotics vs magnesium oxide, Outcome 4: Faecal incontinence, or encopresis, measured at end of study (continuous)

**3.5. Analysis**
Comparison 3: Probiotics vs magnesium oxide, Outcome 5: Need for additional therapies during the study period (continuous data)

**3.6. Analysis**
Comparison 3: Probiotics vs magnesium oxide, Outcome 6: Total adverse events

**4.1. Analysis**
Comparison 4: Synbiotics vs placebo, Outcome 1: Global improvement or treatment success, as defined by primary studies

**4.2. Analysis**
Comparison 4: Synbiotics vs placebo, Outcome 2: Global improvement or treatment success, as defined by primary studies (sensitivity analysis fixed‐effect model))

**4.3. Analysis**
Comparison 4: Synbiotics vs placebo, Outcome 3: Faecal incontinence, or encopresis, measured at end of study (dichotomous)

**4.4. Analysis**
Comparison 4: Synbiotics vs placebo, Outcome 4: Need for additional therapies during the study period

**4.5. Analysis**
Comparison 4: Synbiotics vs placebo, Outcome 5: Total adverse events

**5.1. Analysis**
Comparison 5: Synbiotics and paraffin vs paraffin, Outcome 1: Frequency of defecation (number of stools/week at end of study)

**5.2. Analysis**
Comparison 5: Synbiotics and paraffin vs paraffin, Outcome 2: Frequency of defecation (number of stools/week at end of study) (sensitivity analysis fixed‐effect model)

**5.3. Analysis**
Comparison 5: Synbiotics and paraffin vs paraffin, Outcome 3: Global improvement or treatment success, as defined by primary studies

**5.4. Analysis**
Comparison 5: Synbiotics and paraffin vs paraffin, Outcome 4: Global improvement or treatment success, as defined by primary studies (sensitivity analysis fixed‐effect model)

**5.5. Analysis**
Comparison 5: Synbiotics and paraffin vs paraffin, Outcome 5: Faecal incontinence, or encopresis, measured at end of study (continuous)

**5.6. Analysis**
Comparison 5: Synbiotics and paraffin vs paraffin, Outcome 6: Total adverse events

**6.1. Analysis**
Comparison 6: Synbiotics vs paraffin, Outcome 1: Frequency of defecation (number of stools/week at end of study)

**6.2. Analysis**
Comparison 6: Synbiotics vs paraffin, Outcome 2: Frequency of defecation (number of stools/week at end of study) (sensitivity analysis fixed‐effect model)

**6.3. Analysis**
Comparison 6: Synbiotics vs paraffin, Outcome 3: Global improvement or treatment success, as defined by primary studies

**6.4. Analysis**
Comparison 6: Synbiotics vs paraffin, Outcome 4: Global improvement or treatment success, as defined by primary studies (sensitivity analysis fixed‐effect model)

**6.5. Analysis**
Comparison 6: Synbiotics vs paraffin, Outcome 5: Faecal incontinence, or encopresis, measured at end of study (continuous)

**6.6. Analysis**
Comparison 6: Synbiotics vs paraffin, Outcome 6: Total adverse events

References

References to studies included in this review Banaszkiewicz 2005 {published data only}

1. Banaszkiewicz A, Bibik A, Szajewska H.Functional constipation in children: a follow-up study [Prospektywna obserwacja dzieci z zaparciem czynnościowym]. Pediatria Współczesna Gastroenterologia, Hepatologia i Żywienie Dziecka 2006;8(1):21-3.
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Basturk 2017 {published data only}

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1. Guerra PV, Lima LN, Souza TC, Mazochi V, Penna FJ, Silva AM, et al.Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: a crossover, double-blind, controlled trial. World Journal of Gastroenterology 2011;17(34):3916-21. [PMID: ]

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Wegner 2018 {published data only}

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Wojtyniak 2017 {published data only}

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References to studies excluded from this review Bekkali 2007 {published data only}

1. Bekkali NL, Bongers ME, Van den Berg MM, Liem O, Benninga MA.The role of a probiotics mixture in the treatment of childhood constipation: a pilot study. Nutrition Journal 2007;6(17):1-6. [PMID: ]

Magro 2014 {published data only}

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Olgac 2013 {published data only}

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Szajewska 2011 {published data only}

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Saneian 2013 {published data only}

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Tabbers 2014

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References to other published versions of this review Wallace 2021

1. Wallace C, Gordon M, Akobeng AK, Saps M, Llanos-Chea A, Febo-Rodriguez L, et al.Probiotics for treatment of chronic constipation in children. Cochrane Database of Systematic Reviews 2021, Issue 5. Art. No: CD014257. [DOI: 10.1002/14651858.CD014257]

Source: PubMed

Probiotics for treatment of chronic constipation in children

Abstract

Conflict of interest statement

Figures

References

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