Clinical trial NCT06310733: The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders
Official title: The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Functional Abdominal Pain Syndrome
Keywords: Functional Abdominal Pain Syndrome
Brain-Gut-Microbiome Axis
microbiome
irritable bowel syndrome
microbiota
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: To measure daily pain score in children with and without FAPDs
timeFrame: 12 weeks
measure: To measure daily pain score in children with and without FAPDs
timeFrame: 12 weeks
measure: To measure daily pain score in children with and without FAPDs
timeFrame: 12 weeks
measure: To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Atchariya Chanpong
Study officials:
References: