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

NCT06310733 | Recruiting Phase 4 DMC

• 1 other identifier: REC 66-517-1-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Abdominal Pain Syndrome

Keywords

Functional Abdominal Pain Syndrome; Brain-Gut-Microbiome Axis; microbiome; irritable bowel syndrome; microbiota

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• To measure daily pain score in children with and without FAPDs

  12 weeks

• To measure daily pain score in children with and without FAPDs

  12 weeks

• To measure daily pain score in children with and without FAPDs

  12 weeks

• To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not

  4 weeks

Study Arms (2)

LGG (ATCC 53103)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

An identical aqueous solution in appearance and taste but without LGG.

Drug: Placebo

Interventions

LGG DRUG

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.

LGG (ATCC 53103)

Placebo DRUG

Participants will take 10 mL of an identical aqueous solution in appearance and taste but without LGG, supplied in a 10-mL dark bottle.

Placebo

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children who
• had any chronic diseases, including neurobehavioral disorders
• received treatment with antibiotics/probiotics in the previous 2 months
• received medication that affects gastrointestinal motility in the previous 1 week
• had a pain history suggestive of functional dyspepsia/aerophagia/abdominal migraine/functional constipation
• exhibited growth failure
• had gastrointestinal obstructions/stricture
• displayed alarming signs of organic condition
• had previous abdominal surgery
• 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)
• had family history of peptic ulcer disease or inflammatory bowel disease

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Atchariya Chanpong

Songkhla, Thailand

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Atchariya Chanpong, M.D, Ph.D.

CONTACT

6674451250; atchariya.c@psu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Gastroenterology and Hepatology, Department of Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 15, 2024
• Study Start: March 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 20, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

TH (1)