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

NCT ID: NCT06310733

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2026-02-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

LGG

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Atchariya Chanpong

Division of Gastroenterology and Hepatology, Department of Pediatrics, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Atchariya Chanpong

Songkhla, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Atchariya Chanpong, M.D, Ph.D.

Role: CONTACT

atchariya.c@psu.ac.th

6674451250

Facility Contacts

Atchariya Chanpong, M.D, Ph.D.

Role: primary

atchariya.c@psu.ac.th

+6674451250

Other Identifiers

REC 66-517-1-1

Identifier Type: -

Identifier Source: org_study_id