ConstipationPhase 4NCT06959758
Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation
A Phase 4 study testing Probiotic Arm in people with Constipation, run by Ferass Abu Hanna at 1 site in Israel.
Trial summary
The goal of this clinical trial is to evaluate whether a probiotic supplement, BioKid LR®, can help maintain normal bowel movements after stopping laxative treatment (PEG 3350) in children aged 6 months to 17 years with functional constipation. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotic Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Aug 2024to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0.5 - 17 years
- Diagnosis of FC based on Rome IV criteria
Who cannot join
- Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction
- Prematurity (<34 weeks)
- S/P intestinal surgery
- Immunodeficiency
- Malignancy
- Children treated with medications associated with constipation. *
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Emek Medical Center
Afula
Inbal Rish, PhD, 00972528877977, inbal_la@clalit.org.il
About this study
Official title: Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial
The goal of this clinical trial is to evaluate whether a probiotic supplement, BioKid LR®, can help maintain normal bowel movements after stopping laxative treatment (PEG 3350) in children aged 6 months to 17 years with functional constipation.
The main questions it aims to answer are:
Read more
Does taking BioKid LR reduce the chance of constipation coming back after stopping PEG? Can BioKid LR help children maintain regular bowel movements without needing to restart laxatives? Researchers will compare children who take BioKid LR with those who take a placebo (an inactive powder) to see if the probiotic helps prevent constipation from returning.
Participants will:
Take PEG 3350 (a common laxative) for 12 weeks along with either BioKid LR or a placebo.
After 12 weeks, begin gradually stopping PEG while continuing with BioKid LR or placebo for another 12 weeks.
Then continue only with BioKid LR or placebo for an additional 28 weeks (total study duration: 52 weeks).
Keep a stool diary to track bowel habits and any side effects. Attend 5 study visits for physical exams and monitoring (weeks 0, 12, 24, 38, 52).
The study includes 80 children and is double-blinded, meaning neither the doctors nor the participants know who is receiving the real probiotic or the placebo.
The primary outcome is how long it takes for constipation to return after stopping PEG, requiring retreatment.
Secondary outcomes include:
How many children still need long-term treatment. How many have regular bowel movements without accidents (in children over 4 years old).
Stool consistency and frequency. Children with certain medical conditions (like celiac disease or hypothyroidism) or who are taking medications that cause constipation cannot participate.
This study is supported by Supherb Group, Israel, but they are not involved in designing or analyzing the research. The study has been approved by an ethics committee and follows international ethical guidelines.
- Conditions
- Constipation
- Being tested
- Probiotic Arm, Placebo
- Keywords
- constipation, laxatives, PEG 350
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ArmDietary supplement
It is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period. The study evaluates whether BioKid LR® helps maintain normal bowel movements after stopping PEG.
PlaceboDrug
A placebo maltodextrin powder is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period.
| Study group | Role | What they receive |
|---|---|---|
| BioKid Arm | Experimental | This arm includes children receiving the BioKid LR probiotic supplement alongside standard laxative treatment (PEG 3350), followed by BioKid LR alone after PEG tapering. Receives: Dietary Supplement: Probiotic Arm |
| Placebo | Placebo comparator | This arm includes children receiving a placebo (maltodextrin powder) alongside standard laxative treatment (PEG 3350), followed by placebo alone after PEG tapering. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Recurrence
Time to recurrence of constipation after PEG withdrawal necessitating retreatment with PEG.
This measures how long it takes for constipation to return after stopping laxative treatment, requiring the child to start PEG again.
Measured: 52 weeks
Secondary outcomes (2)
Intractable Constipation
Prevalence of intractable constipation after the initial 12 weeks of PEG treatment
Measured: 12 weeks
Normal Bowel Movements without PEG
Failure to maintain normal bowel movements (defined as > 3 spontaneous bowel movement per week) with no fecal incontinence (among children older than 4 year old) without necessitating PEG re-treatment, at weeks 24 and 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start6 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferass Abu Hanna
- Sponsor type
- University, hospital or other
- Collaborators
- Ambrosia - SupHerb Ltd.
- Responsible party
- Sponsor-investigator, Ferass Abu Hanna, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959758
- Sponsor's protocol ID
- 0151-23-EMC
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eskesen D, Jespersen L, Michelsen B, Whorwell PJ, Muller-Lissner S, Morberg CM. Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12(R), on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial. Br J Nutr. 2015 Nov 28;114(10):1638-46. doi: 10.1017/S0007114515003347. Epub 2015 Sep 18.
PubMed 26382580Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr. 2005 Mar;146(3):364-9. doi: 10.1016/j.jpeds.2004.10.022.
PubMed 15756221Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.
PubMed 26348685Bongers ME, van Wijk MP, Reitsma JB, Benninga MA. Long-term prognosis for childhood constipation: clinical outcomes in adulthood. Pediatrics. 2010 Jul;126(1):e156-62. doi: 10.1542/peds.2009-1009. Epub 2010 Jun 7.
PubMed 20530072Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.
PubMed 24345831Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
PubMed 21382575
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06959758
- Acronym / sponsor ID
- 0151-23-EMC
- Conditions
- Constipation
- Keywords
- constipation, laxatives, PEG 350
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ferass Abu HannaUniversity, hospital or other
- Collaborators
- Ambrosia - SupHerb Ltd.
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 May 2025 (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 evaluate whether a probiotic supplement, BioKid LR®, can help maintain normal bowel movements after stopping laxative treatment (PEG 3350) in children aged 6 months to 17 years with functional constipation.
The main questions it aims to answer are:
Does taking BioKid LR reduce the chance of constipation coming back after stopping PEG? Can BioKid LR help children maintain regular bowel movements without needing to restart laxatives? Researchers will compare children who take BioKid LR with those who take a placebo (an inactive powder) to see if the probiotic helps prevent constipation from returning.
Participants will:
Take PEG 3350 (a common laxative) for 12 weeks along with either BioKid LR or a placebo.
After 12 weeks, begin gradually stopping PEG while continuing with BioKid LR or placebo for another 12 weeks.
Then continue only with BioKid LR or placebo for an additional 28 weeks (total study duration: 52 weeks).
Keep a stool diary to track bowel habits and any side effects. Attend 5 study visits for physical exams and monitoring (weeks 0, 12, 24, 38, 52).
The study includes 80 children and is double-blinded, meaning neither the doctors nor the participants know who is receiving the real probiotic or the placebo.
The primary outcome is how long it takes for constipation to return after stopping PEG, requiring retreatment.
Secondary outcomes include:
How many children still need long-term treatment. How many have regular bowel movements without accidents (in children over 4 years old).
Stool consistency and frequency. Children with certain medical conditions (like celiac disease or hypothyroidism) or who are taking medications that cause constipation cannot participate.
This study is supported by Supherb Group, Israel, but they are not involved in designing or analyzing the research. The study has been approved by an ethics committee and follows international ethical guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioKid Arm | Experimental | Dietary Supplement: Probiotic ArmThis arm includes children receiving the BioKid LR probiotic supplement alongside standard laxative treatment (PEG 3350), followed by BioKid LR alone after PEG tapering. |
| Placebo | Placebo comparator | Drug: PlaceboThis arm includes children receiving a placebo (maltodextrin powder) alongside standard laxative treatment (PEG 3350), followed by placebo alone after PEG tapering. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 0.5 - 17 years
- Diagnosis of FC based on Rome IV criteria
Key exclusion criteria (6 listed)
- Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction
- Prematurity (<34 weeks)
- S/P intestinal surgery
- Immunodeficiency
- Malignancy
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 |
|---|---|---|
| Probiotic ArmIt is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period. The study evaluates whether BioKid LR® helps maintain normal bowel movements after stopping PEG. | Dietary supplement | BioKid Arm |
| PlaceboA placebo maltodextrin powder is administered daily to children with functional constipation, alongside standard laxative treatment (PEG 3350) for the first 12 weeks, and then continued alone for the remainder of the 52-week study period. | Drug | Placebo |
Primary outcome
Constipation Recurrence
Time frame: 52 weeks
Time to recurrence of constipation after PEG withdrawal necessitating retreatment with PEG. This measures how long it takes for constipation to return after stopping laxative treatment, requiring the child to start PEG again.
2 secondary outcomes
Intractable Constipation
Time frame: 12 weeks
Normal Bowel Movements without PEG
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Results publication: PubMed 26382580Eskesen D, Jespersen L, Michelsen B, Whorwell PJ, Muller-Lissner S, Morberg CM. Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12(R), on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial. Br J Nutr. 2015 Nov 28;114(10):1638-46. doi: 10.1017/S0007114515003347. Epub 2015 Sep 18.
- Results publication: PubMed 15756221Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr. 2005 Mar;146(3):364-9. doi: 10.1016/j.jpeds.2004.10.022.
- Results publication: PubMed 26348685Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.
- Results publication: PubMed 20530072Bongers ME, van Wijk MP, Reitsma JB, Benninga MA. Long-term prognosis for childhood constipation: clinical outcomes in adulthood. Pediatrics. 2010 Jul;126(1):e156-62. doi: 10.1542/peds.2009-1009. Epub 2010 Jun 7.
- Results publication: PubMed 24345831Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.
- Results publication: PubMed 21382575Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
- Individual participant dataSharing planned: Undecided
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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.
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 Probiotic Arm in people with Constipation, run by Ferass Abu Hanna at 1 site in Israel.
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 6 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferass Abu Hanna, MD (00972546336583, ferass@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Recurrence (time frame: 52 weeks). 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 NCT06959758, which also lists 6 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 May 2025.