Constipation - FunctionalPHGG-LGG-FCNCT07580729
PHGG-LGG Synbiotic in Pediatric Functional Constipation
A study testing 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG in people with Constipation - Functional, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized controlled open-label trial evaluated the efficacy of a synbiotic consisting of partially hydrolyzed guar gum (PHGG) and Lacticaseibacillus rhamnosus GG (LGG) on clinical outcomes and gut microbiota in children with functional constipation. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 31 Dec 2024
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥4 years
- Diagnosis of functional constipation per Rome IV
- Parental informed consent
Who cannot join
- Organic causes of constipation
- Chronic medication use
- Antibiotics or biotics within 8 weeks
- Age <4 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Sancaktepe Training and Research Hospital
Istanbul, 34000
About this study
Official title: Effects of a Partially Hydrolyzed Guar Gum and Lacticaseibacillus Rhamnosus GG Combination on Clinical Outcomes and Microbiota in Children With Functional Constipation
This prospective, randomized controlled open-label trial evaluated the efficacy of a synbiotic consisting of partially hydrolyzed guar gum (PHGG) and Lacticaseibacillus rhamnosus GG (LGG) on clinical outcomes and gut microbiota in children with functional constipation. Children aged 4-16 years meeting Rome IV criteria were randomized to receive either synbiotic supplementation plus dietary counseling or dietary counseling alone for 12 weeks. Clinical outcomes, gastrointestinal symptoms, and stool microbiota (shotgun metagenomics) were assessed at baseline and at week 12.
Read the detailed description
Functional constipation is common in children and has been associated with gut microbiota dysbiosis and impaired short-chain fatty acid production. Synbiotics combining prebiotics and probiotics may improve stool characteristics and intestinal fermentation.
This study investigated whether daily supplementation with PHGG (4.3 g) plus LGG (1×10⁹ CFU) for 12 weeks improves stool frequency, consistency, gastrointestinal symptoms, and microbiota composition compared with standard dietary advice alone. Whole-genome shotgun metagenomics was performed in a subset of participants to characterize microbial and functional changes.
This study was registered retrospectively on ClinicalTrials.gov because it was initiated as an investigator-initiated academic study without initial intent for regulatory submission. Registration was completed after study completion to ensure transparency and compliance with journal and international reporting standards.
- Conditions
- Constipation - Functional
- Being tested
- 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG, Control
- Keywords
- functional constipation, probiotic, synbiotic, LGG, partially hydrolyzed guar gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GGDietary supplement
4.3 g partially hydrolyzed guar gum
1×10⁹ CFU Lacticaseibacillus rhamnosus GG
Once daily, oral, 12 weeks
Plus standardized dietary and lifestyle counseling
ControlOther
Dietary and lifestyle counseling only
| Study group | Role | What they receive |
|---|---|---|
| LGG-PHGG | Experimental | PHGG + LGG Synbiotic
4.3 g partially hydrolyzed guar gum
1×10⁹ CFU Lacticaseibacillus rhamnosus GG
Once daily, oral, 12 weeks
Plus standardized dietary and lifestyle counseling Receives: Dietary Supplement: 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG; Other: Control |
| Control | Active comparator | Dietary and lifestyle counseling only Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical treatment success at Week 12
Clinical treatment success at Week 12, defined as:
≥3 spontaneous bowel movements per week AND
Bristol Stool Scale type 3-4 AND
No longer fulfilling Rome IV criteria
Measured: 12 weeks
Secondary outcomes (4)
Time to First Symptom Improvement
Time (in days) from initiation of the intervention to the first reported improvement in constipation-related symptoms
Measured: 12 weeks
Microbiota
Gut microbiota composition changes
Measured: 12 weeks
Time to Second Improvement Milestone
Time (in days) from initiation of the intervention to the second clinically meaningful improvement milestone, defined as sustained improvement in bowel movement frequency and/or stool consistency accompanied by reduction in associated gastrointestinal symptoms, as documented in daily follow-up records.
Measured: Baseline to 12 week
School Absenteeism
Number of school days missed and presence of school absenteeism due to constipation-related symptoms, as reported by parents during the study period.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Aug 2024
- Primary completion1 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Responsible party
- Principal investigator, Ener Cagri DINLEYICI, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580729
- Sponsor's protocol ID
- 2024/197
- Acronym
- PHGG-LGG-FC
- Status last verified
- May 2026
- First submitted
- 14 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Partially Hydrolyzed Guar Gum and Lacticaseibacillus Rhamnosus GG Combination on Clinical Outcomes and Microbiota in Children With Functional Constipation
- ClinicalTrials.gov ID
- NCT07580729
- Acronym / sponsor ID
- PHGG-LGG-FC / 2024/197
- Conditions
- Constipation - Functional
- Keywords
- functional constipation, probiotic, synbiotic, LGG, partially hydrolyzed guar gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 May 2026 (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.
This prospective, randomized controlled open-label trial evaluated the efficacy of a synbiotic consisting of partially hydrolyzed guar gum (PHGG) and Lacticaseibacillus rhamnosus GG (LGG) on clinical outcomes and gut microbiota in children with functional constipation. Children aged 4-16 years meeting Rome IV criteria were randomized to receive either synbiotic supplementation plus dietary counseling or dietary counseling alone for 12 weeks. Clinical outcomes, gastrointestinal symptoms, and stool microbiota (shotgun metagenomics) were assessed at baseline and at week 12.
Detailed description
Functional constipation is common in children and has been associated with gut microbiota dysbiosis and impaired short-chain fatty acid production. Synbiotics combining prebiotics and probiotics may improve stool characteristics and intestinal fermentation.
This study investigated whether daily supplementation with PHGG (4.3 g) plus LGG (1×10⁹ CFU) for 12 weeks improves stool frequency, consistency, gastrointestinal symptoms, and microbiota composition compared with standard dietary advice alone. Whole-genome shotgun metagenomics was performed in a subset of participants to characterize microbial and functional changes.
This study was registered retrospectively on ClinicalTrials.gov because it was initiated as an investigator-initiated academic study without initial intent for regulatory submission. Registration was completed after study completion to ensure transparency and compliance with journal and international reporting standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG-PHGG | Experimental | Dietary Supplement: 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG, Other: ControlPHGG + LGG Synbiotic 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG Once daily, oral, 12 weeks Plus standardized dietary and lifestyle counseling |
| Control | Active comparator | Other: ControlDietary and lifestyle counseling only |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ≥4 years
- Diagnosis of functional constipation per Rome IV
- Parental informed consent
Key exclusion criteria (4 listed)
- Organic causes of constipation
- Chronic medication use
- Antibiotics or biotics within 8 weeks
- Age <4 years
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 |
|---|---|---|
| 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG Once daily, oral, 12 weeks Plus standardized dietary and lifestyle counseling | Dietary supplement | LGG-PHGG |
| ControlDietary and lifestyle counseling only | Other | Control, LGG-PHGG |
Primary outcome
Clinical treatment success at Week 12
Time frame: 12 weeks
Clinical treatment success at Week 12, defined as: ≥3 spontaneous bowel movements per week AND Bristol Stool Scale type 3-4 AND No longer fulfilling Rome IV criteria
4 secondary outcomes
Time to First Symptom Improvement
Time frame: 12 weeks
Microbiota
Time frame: 12 weeks
Time to Second Improvement Milestone
Time frame: Baseline to 12 week
School Absenteeism
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4.3 g partially hydrolyzed guar gum 1×10⁹ CFU Lacticaseibacillus rhamnosus GG in people with Constipation - Functional, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 12 May 2026. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical treatment success at Week 12 (time frame: 12 weeks). 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 12 May 2026.