The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders

The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders - A Randomized Controlled Trial

Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless be severe enough to impair the patient's quality of life, growth, and development. To help rule out organic disorders and diagnose this condition, some individuals underwent multiple invasive and costly studies.

Generally, the diagnosis of FAPDs is based on clinical symptoms and criteria, it can be divided into irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP) and functional dyspepsia (FD). Approximately 14% of children globally, between the ages of 4 and 18, experience functional abdominal pain issues8. In Thailand, the prevalence of FAPDs among adolescents (mean age of 16 years) was 5.3%, functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes.

The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis, which may happen early in life or throughout. Hence, several studies, specifically in western countries, reported the role of probiotics, specifically Lactobacillus rhamnosus GG (LGG), in modulating abdominal symptoms in children with FAPDs.

It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity, mode of delivery, dietary and environmental factors. However, the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries. Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs, the investigators aim to evaluate the effects of probiotics, LGG, in the treatment of children who suffered from FAPDs.

The secondary objectives are to measure daily pain score in children with and without FAPDs, to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs, and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not.

Study Overview

• Status: Recruiting
• Conditions: Functional Abdominal Pain Syndrome
• Intervention / Treatment: Drug: LGG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Atchariya Chanpong, M.D, Ph.D.; Phone Number: 6674451250; Email: atchariya.c@psu.ac.th

Study Locations

• Thailand
  • Songkhla, Thailand
    • Recruiting
    • Atchariya Chanpong
    • Contact: Atchariya Chanpong, M.D, Ph.D.; Phone Number: +6674451250; Email: atchariya.c@psu.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children, aged 6-15 years old, with a diagnosis of IBS or FAP, according to the Rome IV diagnostic criteria. The diagnosis of IBS or FAP was based on a clinical interview performed by pediatric gastroenterologist.

For healthy controls: non-obese children, aged 6-15 years old, without any gastrointestinal symptoms at the time of recruitment.

Exclusion Criteria:

• Children who

  1. had any chronic diseases, including neurobehavioral disorders
  2. received treatment with antibiotics/probiotics in the previous 2 months
  3. received medication that affects gastrointestinal motility in the previous 1 week
  4. had a pain history suggestive of functional dyspepsia/aerophagia/abdominal migraine/functional constipation
  5. exhibited growth failure
  6. had gastrointestinal obstructions/stricture
  7. displayed alarming signs of organic condition
  8. had previous abdominal surgery
  9. had abnormal baseline test results as part of their standard work-up (e.g. complete blood counts; erythrocyte sedimentation rate; liver-pancreas-kidney function tests; stool examination for occult blood, ova, and parasites; fecal calprotectin; urinalysis; abdominal ultrasound; 13C-urea breath test; gastric emptying study, if any)
  10. had family history of peptic ulcer disease or inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LGG (ATCC 53103); A suspension of freeze-dried LGG ATCC53103 in excipients in an aqueous solution supplied in a 10-mL dark bottle with a delivery cap.	Drug: LGG; Participants will take 10 mL of a suspension of freeze-dried LGG ATCC53103 in excipients in an aqueous solution, supplied in a 10-mL dark bottle with a delivery cap.
Placebo Comparator: Placebo; An identical aqueous solution in appearance and taste but without LGG.	Drug: Placebo; Participants will take 10 mL of an identical aqueous solution in appearance and taste but without LGG, supplied in a 10-mL dark bottle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs	Faces pain scale (0-6); higher scores mean a worse outcome.	12 weeks
The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs	Visual analog scale (0-10); higher scores mean a worse outcome.	12 weeks
The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs	Daily food and symptom record	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure daily pain score in children with and without FAPDs	Faces pain scale (0-6); higher scores mean a worse outcome.	12 weeks
To measure daily pain score in children with and without FAPDs	Visual analog scale (0-10); higher scores mean a worse outcome.	12 weeks
To measure daily pain score in children with and without FAPDs	Daily food and symptom record	12 weeks
To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not	stool samples for rDNA sequencing before and after 4 weeks of treatment.	4 weeks

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Estimated): March 21, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: microbiome; microbiota; irritable bowel syndrome; Functional Abdominal Pain Syndrome; Brain-Gut-Microbiome Axis
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Syndrome; Abdominal Pain; Somatoform Disorders
• Other Study ID Numbers: REC 66-517-1-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No