Functional Abdominal Pain SyndromePhase 4NCT06310733
The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders
A Phase 4 study testing LGG in people with Functional Abdominal Pain Syndrome, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- LGG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- 21 Mar 2024to 20 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Atchariya Chanpong
Songkhla
Atchariya Chanpong, M.D, Ph.D., +6674451250, atchariya.c@psu.ac.th
About this study
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
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.
Read more
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
- Being tested
- LGG, Placebo
- Keywords
- Functional Abdominal Pain Syndrome, Brain-Gut-Microbiome Axis, microbiome, irritable bowel syndrome, microbiota
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGGDrug
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.
PlaceboDrug
Participants will take 10 mL of an identical aqueous solution in appearance and taste but without LGG, supplied in a 10-mL dark bottle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: LGG |
| Placebo | Placebo comparator | An identical aqueous solution in appearance and taste but without LGG. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 12 weeks
Secondary outcomes (4)
To measure daily pain score in children with and without FAPDs
Faces pain scale (0-6); higher scores mean a worse outcome.
Measured: 12 weeks
To measure daily pain score in children with and without FAPDs
Visual analog scale (0-10); higher scores mean a worse outcome.
Measured: 12 weeks
To measure daily pain score in children with and without FAPDs
Daily food and symptom record
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start21 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atchariya Chanpong, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310733
- Sponsor's protocol ID
- REC 66-517-1-1
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06310733
- Acronym / sponsor ID
- REC 66-517-1-1
- Conditions
- Functional Abdominal Pain Syndrome
- Keywords
- Functional Abdominal Pain Syndrome, Brain-Gut-Microbiome Axis, microbiome, irritable bowel syndrome, microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG (ATCC 53103) | Experimental | Drug: LGGA suspension of freeze-dried LGG ATCC53103 in excipients in an aqueous solution supplied in a 10-mL dark bottle with a delivery cap. |
| Placebo | Placebo comparator | Drug: PlaceboAn identical aqueous solution in appearance and taste but without LGG. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- Children who
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGGParticipants 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. | Drug | LGG (ATCC 53103) |
| PlaceboParticipants will take 10 mL of an identical aqueous solution in appearance and taste but without LGG, supplied in a 10-mL dark bottle. | Drug | Placebo |
Primary outcome
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
Time frame: 12 weeks
Faces pain scale (0-6); higher scores mean a worse outcome.
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
Time frame: 12 weeks
Visual analog scale (0-10); higher scores mean a worse outcome.
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
Time frame: 12 weeks
Daily food and symptom record
4 secondary outcomes
To measure daily pain score in children with and without FAPDs
Time frame: 12 weeks
To measure daily pain score in children with and without FAPDs
Time frame: 12 weeks
To measure daily pain score in children with and without FAPDs
Time frame: 12 weeks
To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LGG in people with Functional Abdominal Pain Syndrome, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atchariya Chanpong, M.D, Ph.D. (6674451250, atchariya.c@psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.