Functional Abdominal Pain SyndromePhase 1/2FAPD_RCTNCT06268964
Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
A Phase 1/2 study testing Trimebutine and Lactobacillus rhamnosus in people with Functional Abdominal Pain Syndrome and Functional Gastrointestinal Disorders, run by Universidad de Colima at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in… Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome Variant of Childhood
- What is being tested?
- Trimebutine and Lactobacillus rhamnosus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2024to 30 Jun 2025
- Phase
- Phase 1/2
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients from 4 to 18 years old.
- Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine or Functional Abdominal Pain Not Otherwise Specified)
- Having the informed consent signed by the parents or legal guardians of the minor.
Who cannot join
- Patients presenting abdominal pain of organic cause.
- Immunosuppressed patients.
- Patients with previous hypersensitivity to the study drug.
- Elimination Criteria:
- Voluntary withdrawal from the study.
- Patients not adhering to treatment (less than 80%)
- Patients participating in another study simultaneously.
- Patients being treated by another doctor simultaneously.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
School of Medicine, University of Colima
Colima, 28040
Pablo H Sandoval-Villaseñor, MD, +523123007655, pablohernan_sandoval@ucol.mx
Fabián Rojas-Larios, PhD, frojas@ucol.mx
About this study
Official title: Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)
The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.
Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.
Read the detailed description
The protocol will be submitted for review by the Research Committee and the Ethics Committee of the Regional University Hospital of Colima. Upon receiving approval, a double-blind, placebo-controlled, randomized clinical trial will be carried out, based on CONSORT guidelines. This trial involves the participation of pediatric patients aged 4 to 18.
Patients will be selected from those attending private practice and satisfying Rome IV criteria for any of the Functional Abdominal Pain Disorders (FAPD). Before any intervention takes place, the purpose and procedures of the study will be explained to both the patients and their legal guardians. If they decide to participate, they will be asked to sign an informed consent letter and assent form for minors. Patients will be selected through stratified probabilistic sampling in 4 categories (Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain not otherwise specified (FAP-NOS)) until the desired sample size of 82 participants is reached. Once participants are selected, they will be randomly assigned to one of the three groups: trimebutine/probiotic, probiotic/placebo, or trimebutine/placebo, with each group consisting of at least 20 participants. The initial diagnosis will be carried out using the Rome IV Criteria Questionnaires for pediatric patients, and the intensity of pain will be evaluated using the Visual Analog Scale (VAS) and quality of life with PedsQL 4.0. Patients will be administered the treatment corresponding to their assigned group and will be clinically followed up at 4 and 8 weeks. During these follow-up consultations, the Rome IV Criteria Questionnaires and scales will be reapplied to assess the evolution of the patients' symptoms and their response to treatment. Any patient who requests voluntary withdrawal, those with treatment adherence less than 80%, and those participating in another study or being treated by another physician simultaneously will be removed from the study.
Statistical analysis will be carried out using international Business Machine (IBM®) Statistical Package for the Social Sciences (SPSS®) Statistics 26. Descriptive statistics with measures of central tendency will be used, presenting the results in tables and graphs. To determine whether the data follow a normal distribution, the Kolmogorov-Smirnov and Shapiro-Wilk tests will be applied. Measurements in 3 groups (trimebutine, probiotics, and control) and at 3 times (0, 4, and 8 weeks) will be analyzed. For intervening categorical variables like gender and education, the chi-square test (X2) will be used. For continuous variables like age and BMI, the Mann-Whitney U test will be applied, expecting statistically significant differences with p < 0.05.
If the data follow a normal distribution, repeated measures ANOVA will be used to compare the means of the 3 groups (trimebutine, probiotics, and placebo). McNemar's test or the sign test will be considered as secondary analyses to evaluate changes within each group over time (0, 4, and 8 weeks). If the data do not follow a normal distribution, non-parametric tests like the Friedman test will be employed.
In case of finding a statistically significant difference in repeated measures ANOVA or the Friedman test, post hoc tests will be performed to identify specific differences between groups and times. If necessary, correlation tests like Pearson or Spearman will be used to evaluate relationships between different variables within the study.
- Conditions
- Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome Variant of Childhood
- Being tested
- Trimebutine, Lactobacillus rhamnosus, Placebo
- Keywords
- functional abdominal pain, randomized clinical trial, placebo, double-blind, trimebutine, Lactobacillus rhamnosus, pediatrics
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimebutineDrug
Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Lactobacillus rhamnosusDietary supplement
Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
PlaceboOther
Also called Microcrystalline cellulose
Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Trimebutine + Probiotic | Experimental | Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets, a single dose (night), for a period of 8 weeks. Receives: Drug: Trimebutine; Dietary Supplement: Lactobacillus rhamnosus |
| Trimebutine + Placebo | Active comparator | Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks. Receives: Drug: Trimebutine; Other: Placebo |
| Probiotic + Placebo | Active comparator | Participants received Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks. Receives: Dietary Supplement: Lactobacillus rhamnosus; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Score on Visual Analog Scale for Abdominal Pain
Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms.
Measured: Baseline to 8 weeks post-treatment.
Secondary outcomes (3)
Improvement in Quality of Life with PedsQL 3.0
Impact of the treatment on the Quality of Life in pediatric patients with FAPD. The PedsQL 0 - 100 scoring system is used, where higher scores indicate better quality of life. The change in scores from baseline to 8 weeks post-treatment is measured.
Measured: Baseline to 8 weeks post-treatment.
Improvement in Quality of Life with PedsQL 3.0
Impact of the treatment on the Quality of Life in pediatric patients with FAPD. The PedsQL 0 - 100 scoring system is used, where higher scores indicate better quality of life. The change in scores from baseline to 4 weeks post-treatment is measured.
Measured: Baseline to 4 weeks post-treatment.
Average Score on Visual Analog Scale for Abdominal Pain
Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms.
Measured: Baseline to 4 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabian Rojas Larios, Universidad de Colima
- Investigators
- Pablo H Sandoval-Villaseñor, MD, Principal investigator, Universidad de ColimaFabián Rojas-Larios, PhD, Study director, Universidad de ColimaCarmen A Sánchez-Ramírez, PhD, Study director, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268964
- Sponsor's protocol ID
- 2023-5
- Acronym
- FAPD_RCT
- Status last verified
- Aug 2024
- First submitted
- 23 Jan 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korterink JJ, Diederen K, Benninga MA, Tabbers MM. Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis. PLoS One. 2015 May 20;10(5):e0126982. doi: 10.1371/journal.pone.0126982. eCollection 2015.
PubMed 25992621Simren M, Tornblom H, Palsson OS, Van Oudenhove L, Whitehead WE, Tack J. Cumulative Effects of Psychologic Distress, Visceral Hypersensitivity, and Abnormal Transit on Patient-reported Outcomes in Irritable Bowel Syndrome. Gastroenterology. 2019 Aug;157(2):391-402.e2. doi: 10.1053/j.gastro.2019.04.019. Epub 2019 Apr 22.
PubMed 31022401Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.
PubMed 33154368Ding FCL, Karkhaneh M, Zorzela L, Jou H, Vohra S. Probiotics for paediatric functional abdominal pain disorders: A rapid review. Paediatr Child Health. 2019 Sep;24(6):383-394. doi: 10.1093/pch/pxz036. Epub 2019 May 4.
PubMed 31528110Horvath A, Dziechciarz P, Szajewska H. Systematic review of randomized controlled trials: fiber supplements for abdominal pain-related functional gastrointestinal disorders in childhood. Ann Nutr Metab. 2012;61(2):95-101. doi: 10.1159/000338965.
PubMed 22889919Chumpitazi BP, Kearns GL, Shulman RJ. Review article: the physiological effects and safety of peppermint oil and its efficacy in irritable bowel syndrome and other functional disorders. Aliment Pharmacol Ther. 2018 Mar;47(6):738-752. doi: 10.1111/apt.14519. Epub 2018 Jan 26.
PubMed 29372567Karabulut GS, Beser OF, Erginoz E, Kutlu T, Cokugras FC, Erkan T. The Incidence of Irritable Bowel Syndrome in Children Using the Rome III Criteria and the Effect of Trimebutine Treatment. J Neurogastroenterol Motil. 2013 Jan;19(1):90-3. doi: 10.5056/jnm.2013.19.1.90. Epub 2013 Jan 8.
PubMed 23350053Wallace C, Gordon M, Sinopoulou V, Akobeng AK. Probiotics for management of functional abdominal pain disorders in children. Cochrane Database Syst Rev. 2023 Feb 17;2(2):CD012849. doi: 10.1002/14651858.CD012849.pub2.
PubMed 36799531Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
PubMed 27144632Khrizman M, Pakalnis A. Management of Pediatric Migraine: Current Therapies. Pediatr Ann. 2018 Feb 1;47(2):e55-e60. doi: 10.3928/19382359-20180129-02.
PubMed 29446795Saps M, Velasco-Benitez CA, Langshaw AH, Ramirez-Hernandez CR. Prevalence of Functional Gastrointestinal Disorders in Children and Adolescents: Comparison Between Rome III and Rome IV Criteria. J Pediatr. 2018 Aug;199:212-216. doi: 10.1016/j.jpeds.2018.03.037. Epub 2018 May 7.
PubMed 29747935Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24.
PubMed 28092724Chiou E, Nurko S. Management of functional abdominal pain and irritable bowel syndrome in children and adolescents. Expert Rev Gastroenterol Hepatol. 2010 Jun;4(3):293-304. doi: 10.1586/egh.10.28.
PubMed 20528117Koppen IJN, Saps M, Lavigne JV, Nurko S, Taminiau JAJM, Di Lorenzo C, Benninga MA. Recommendations for pharmacological clinical trials in children with functional constipation: The Rome foundation pediatric subcommittee on clinical trials. Neurogastroenterol Motil. 2018 Apr;30(4):e13294. doi: 10.1111/nmo.13294. Epub 2018 Jan 30.
PubMed 29380480Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
PubMed 27144631
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT06268964
- Acronym / sponsor ID
- FAPD_RCT / 2023-5
- Conditions
- Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome Variant of Childhood
- Keywords
- functional abdominal pain, randomized clinical trial, placebo, double-blind, trimebutine, Lactobacillus rhamnosus, pediatrics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Feb 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.
The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.
Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.
Detailed description
The protocol will be submitted for review by the Research Committee and the Ethics Committee of the Regional University Hospital of Colima. Upon receiving approval, a double-blind, placebo-controlled, randomized clinical trial will be carried out, based on CONSORT guidelines. This trial involves the participation of pediatric patients aged 4 to 18.
Patients will be selected from those attending private practice and satisfying Rome IV criteria for any of the Functional Abdominal Pain Disorders (FAPD). Before any intervention takes place, the purpose and procedures of the study will be explained to both the patients and their legal guardians. If they decide to participate, they will be asked to sign an informed consent letter and assent form for minors. Patients will be selected through stratified probabilistic sampling in 4 categories (Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain not otherwise specified (FAP-NOS)) until the desired sample size of 82 participants is reached. Once participants are selected, they will be randomly assigned to one of the three groups: trimebutine/probiotic, probiotic/placebo, or trimebutine/placebo, with each group consisting of at least 20 participants. The initial diagnosis will be carried out using the Rome IV Criteria Questionnaires for pediatric patients, and the intensity of pain will be evaluated using the Visual Analog Scale (VAS) and quality of life with PedsQL 4.0. Patients will be administered the treatment corresponding to their assigned group and will be clinically followed up at 4 and 8 weeks. During these follow-up consultations, the Rome IV Criteria Questionnaires and scales will be reapplied to assess the evolution of the patients' symptoms and their response to treatment. Any patient who requests voluntary withdrawal, those with treatment adherence less than 80%, and those participating in another study or being treated by another physician simultaneously will be removed from the study.
Statistical analysis will be carried out using international Business Machine (IBM®) Statistical Package for the Social Sciences (SPSS®) Statistics 26. Descriptive statistics with measures of central tendency will be used, presenting the results in tables and graphs. To determine whether the data follow a normal distribution, the Kolmogorov-Smirnov and Shapiro-Wilk tests will be applied. Measurements in 3 groups (trimebutine, probiotics, and control) and at 3 times (0, 4, and 8 weeks) will be analyzed. For intervening categorical variables like gender and education, the chi-square test (X2) will be used. For continuous variables like age and BMI, the Mann-Whitney U test will be applied, expecting statistically significant differences with p < 0.05.
If the data follow a normal distribution, repeated measures ANOVA will be used to compare the means of the 3 groups (trimebutine, probiotics, and placebo). McNemar's test or the sign test will be considered as secondary analyses to evaluate changes within each group over time (0, 4, and 8 weeks). If the data do not follow a normal distribution, non-parametric tests like the Friedman test will be employed.
In case of finding a statistically significant difference in repeated measures ANOVA or the Friedman test, post hoc tests will be performed to identify specific differences between groups and times. If necessary, correlation tests like Pearson or Spearman will be used to evaluate relationships between different variables within the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trimebutine + Probiotic | Experimental | Drug: Trimebutine, Dietary Supplement: Lactobacillus rhamnosusParticipants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets, a single dose (night), for a period of 8 weeks. |
| Trimebutine + Placebo | Active comparator | Drug: Trimebutine, Other: PlaceboParticipants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks. |
| Probiotic + Placebo | Active comparator | Dietary Supplement: Lactobacillus rhamnosus, Other: PlaceboParticipants received Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients from 4 to 18 years old.
- Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine or Functional Abdominal Pain Not Otherwise Specified)
- Having the informed consent signed by the parents or legal guardians of the minor.
Key exclusion criteria (8 listed)
- Patients presenting abdominal pain of organic cause.
- Immunosuppressed patients.
- Patients with previous hypersensitivity to the study drug.
- Voluntary withdrawal from the study.
- Patients not adhering to treatment (less than 80%)
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 |
|---|---|---|
| TrimebutinePrescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks. | Drug | Trimebutine + Placebo, Trimebutine + Probiotic |
| Lactobacillus rhamnosusPrescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks. | Dietary supplement | Probiotic + Placebo, Trimebutine + Probiotic |
| PlaceboAlso: Microcrystalline cellulosePrescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks. | Other | Probiotic + Placebo, Trimebutine + Placebo |
Primary outcome
Average Score on Visual Analog Scale for Abdominal Pain
Time frame: Baseline to 8 weeks post-treatment.
Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms.
3 secondary outcomes
Improvement in Quality of Life with PedsQL 3.0
Time frame: Baseline to 8 weeks post-treatment.
Improvement in Quality of Life with PedsQL 3.0
Time frame: Baseline to 4 weeks post-treatment.
Average Score on Visual Analog Scale for Abdominal Pain
Time frame: Baseline to 4 weeks post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 25992621Korterink JJ, Diederen K, Benninga MA, Tabbers MM. Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis. PLoS One. 2015 May 20;10(5):e0126982. doi: 10.1371/journal.pone.0126982. eCollection 2015.
- Background: PubMed 31022401Simren M, Tornblom H, Palsson OS, Van Oudenhove L, Whitehead WE, Tack J. Cumulative Effects of Psychologic Distress, Visceral Hypersensitivity, and Abnormal Transit on Patient-reported Outcomes in Irritable Bowel Syndrome. Gastroenterology. 2019 Aug;157(2):391-402.e2. doi: 10.1053/j.gastro.2019.04.019. Epub 2019 Apr 22.
- Background: PubMed 33154368Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.
- Background: PubMed 31528110Ding FCL, Karkhaneh M, Zorzela L, Jou H, Vohra S. Probiotics for paediatric functional abdominal pain disorders: A rapid review. Paediatr Child Health. 2019 Sep;24(6):383-394. doi: 10.1093/pch/pxz036. Epub 2019 May 4.
- Background: PubMed 22889919Horvath A, Dziechciarz P, Szajewska H. Systematic review of randomized controlled trials: fiber supplements for abdominal pain-related functional gastrointestinal disorders in childhood. Ann Nutr Metab. 2012;61(2):95-101. doi: 10.1159/000338965.
- Background: PubMed 29372567Chumpitazi BP, Kearns GL, Shulman RJ. Review article: the physiological effects and safety of peppermint oil and its efficacy in irritable bowel syndrome and other functional disorders. Aliment Pharmacol Ther. 2018 Mar;47(6):738-752. doi: 10.1111/apt.14519. Epub 2018 Jan 26.
- Background: PubMed 23350053Karabulut GS, Beser OF, Erginoz E, Kutlu T, Cokugras FC, Erkan T. The Incidence of Irritable Bowel Syndrome in Children Using the Rome III Criteria and the Effect of Trimebutine Treatment. J Neurogastroenterol Motil. 2013 Jan;19(1):90-3. doi: 10.5056/jnm.2013.19.1.90. Epub 2013 Jan 8.
- Background: PubMed 36799531Wallace C, Gordon M, Sinopoulou V, Akobeng AK. Probiotics for management of functional abdominal pain disorders in children. Cochrane Database Syst Rev. 2023 Feb 17;2(2):CD012849. doi: 10.1002/14651858.CD012849.pub2.
- Background: PubMed 27144632Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
- Background: PubMed 29446795Khrizman M, Pakalnis A. Management of Pediatric Migraine: Current Therapies. Pediatr Ann. 2018 Feb 1;47(2):e55-e60. doi: 10.3928/19382359-20180129-02.
- Background: PubMed 29747935Saps M, Velasco-Benitez CA, Langshaw AH, Ramirez-Hernandez CR. Prevalence of Functional Gastrointestinal Disorders in Children and Adolescents: Comparison Between Rome III and Rome IV Criteria. J Pediatr. 2018 Aug;199:212-216. doi: 10.1016/j.jpeds.2018.03.037. Epub 2018 May 7.
- Background: PubMed 28092724Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24.
- Individual participant dataSharing planned: No
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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.
Pablo H Sandoval-Villaseñor, MD principal investigator
Universidad de Colima
Fabián Rojas-Larios, PhD study director
Universidad de Colima
Carmen A Sánchez-Ramírez, PhD study director
Universidad de Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trimebutine and Lactobacillus rhamnosus in people with Functional Abdominal Pain Syndrome and Functional Gastrointestinal Disorders, run by Universidad de Colima at 1 site in Mexico.
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 3 inclusion and 8 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 16 Aug 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 Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Pablo H Sandoval-Villaseñor, MD (+523123007655, pablohernan_sandoval@ucol.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Score on Visual Analog Scale for Abdominal Pain (time frame: Baseline to 8 weeks post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268964, which also lists 32 linked publications.
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 16 Aug 2024.