Fecal Microbiota TransplantationNCT05035784
RCE With FMT in the Treatment of Childhood Constipation
A study testing Fecal supernatant in people with Fecal Microbiota Transplantation and Constipation - Functional, run by Shengjing Hospital at 1 site in China.
Trial summary
Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Microbiota Transplantation, Constipation - Functional
- What is being tested?
- Fecal supernatant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 13 May 2022
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-14 years old;
- Roman IV criteria for childhood constipation;
- After a course of PEG and a course of Chinese medicine treatment was ineffective;
- Barium enema showing fecal impaction.
Who cannot join
- Congenital and/or acquired intestinal diseases, such as congenital megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumors;
- Anorectal diseases, such as anal atresia, fistula, abscess, and tumor;
- Neurological diseases, such as brain and spinal cord diseases;
- genetic metabolic diseases;
- psychosocial and behavioral diseases;
- other systemic diseases;
- Refused to participate in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation
Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease.
Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.
- Being tested
- Fecal supernatant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal supernatantDrug
Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .
PlaceboDrug
a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.
| Study group | Role | What they receive |
|---|---|---|
| Fecal supernatant | Active comparator | Fecal supernatant is used for treatment of childhood Constipation Receives: Drug: Fecal supernatant |
| non-Fecal supernatant | Placebo comparator | Placebo is used for treatment of childhood Constipation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of spontaneous bowel movements(SBMs) per week
the frequency of defecation without drugs or other auxiliary methods
Measured: Baseline
improvement of spontaneous bowel movements(SBMs) per week
the frequency of defecation without drugs or other auxiliary methods
Measured: at the end of 4-weeks FMT treatment
improvement of spontaneous bowel movements(SBMs) per week
the frequency of defecation without drugs or other auxiliary methods
Measured: at the end of 12 weeks follow-up
Satisfaction with bowel function
Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Measured: Baseline
Satisfaction with bowel function
Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Measured: at the end of 4-weeks FMT treatment
Satisfaction with bowel function
Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Measured: at the end of 12 weeks follow-up
Secondary outcomes (15)
Bowel movements
the frequency of bowel movements per week
Measured: Baseline
Bowel movements
the frequency of bowel movements per week
Measured: at the end of 4-weeks FMT treatment
Bowel movements
the frequency of bowel movements per week
Measured: at the end of 12 weeks follow-up
Painful or hard bowel movements
The feelings of children during defecation
Measured: Baseline
Painful or hard bowel movements
The feelings of children during defecation
Measured: at the end of 4-weeks FMT treatment
Painful or hard bowel movements
The feelings of children during defecation
Measured: at the end of 12 weeks follow-up
Large diameter or scybalous stools
appearance and wetness of stool
Measured: Baseline
Large diameter or scybalous stools
appearance and wetness of stool
Measured: at the end of 4-weeks FMT treatment
Large diameter or scybalous stools
appearance and wetness of stool
Measured: at the end of 12 weeks follow-up
Excessive volitional stool retention
The number of children who intentionally control or reduce the frequency of defecation
Measured: Baseline
Excessive volitional stool retention
The number of children who intentionally control or reduce the frequency of defecation
Measured: at the end of 4-weeks FMT treatment
Excessive volitional stool retention
The number of children who intentionally control or reduce the frequency of defecation
Measured: at the end of 12 weeks follow-up
Encopresis
the frequency of fecal incontinence
Measured: Baseline
Encopresis
the frequency of fecal incontinence
Measured: at the end of 4-weeks FMT treatment
Encopresis
the frequency of fecal incontinence
Measured: at the end of 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start10 Nov 2020
- Primary completion20 Jan 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shucheng Zhang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035784
- Sponsor's protocol ID
- A333--1
- Status last verified
- Nov 2023
- First submitted
- 26 Aug 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.
PubMed 27529553Gurram B, Sue PK. Fecal microbiota transplantation in children: current concepts. Curr Opin Pediatr. 2019 Oct;31(5):623-629. doi: 10.1097/MOP.0000000000000787.
PubMed 31169545Xu D, Chen VL, Steiner CA, Berinstein JA, Eswaran S, Waljee AK, Higgins PDR, Owyang C. Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Jul;114(7):1043-1050. doi: 10.14309/ajg.0000000000000198.
PubMed 30908299Tian H, Ding C, Gong J, Ge X, McFarland LV, Gu L, Wei Y, Chen Q, Zhu W, Li J, Li N. Treatment of Slow Transit Constipation With Fecal Microbiota Transplantation: A Pilot Study. J Clin Gastroenterol. 2016 Nov/Dec;50(10):865-870. doi: 10.1097/MCG.0000000000000472.
PubMed 26751143Ohkusa T, Koido S, Nishikawa Y, Sato N. Gut Microbiota and Chronic Constipation: A Review and Update. Front Med (Lausanne). 2019 Feb 12;6:19. doi: 10.3389/fmed.2019.00019. eCollection 2019.
PubMed 30809523Kassam Z, Dubois N, Ramakrishna B, Ling K, Qazi T, Smith M, Kelly CR, Fischer M, Allegretti JR, Budree S, Panchal P, Kelly CP, Osman M. Donor Screening for Fecal Microbiota Transplantation. N Engl J Med. 2019 Nov 21;381(21):2070-2072. doi: 10.1056/NEJMc1913670. Epub 2019 Oct 30. No abstract available.
PubMed 31665572Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
PubMed 22002980Vriesman MH, Koppen IJN, Camilleri M, Di Lorenzo C, Benninga MA. Management of functional constipation in children and adults. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):21-39. doi: 10.1038/s41575-019-0222-y. Epub 2019 Nov 5.
PubMed 31690829Clemente MG, Mandato C, Poeta M, Vajro P. Pediatric non-alcoholic fatty liver disease: Recent solutions, unresolved issues, and future research directions. World J Gastroenterol. 2016 Sep 28;22(36):8078-93. doi: 10.3748/wjg.v22.i36.8078.
PubMed 27688650Woodworth MH, Carpentieri C, Sitchenko KL, Kraft CS. Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review. Gut Microbes. 2017 May 4;8(3):225-237. doi: 10.1080/19490976.2017.1286006. Epub 2017 Jan 27.
PubMed 28129018Vindigni SM, Surawicz CM. Fecal Microbiota Transplantation. Gastroenterol Clin North Am. 2017 Mar;46(1):171-185. doi: 10.1016/j.gtc.2016.09.012.
PubMed 28164849Shen ZH, Zhu CX, Quan YS, Yang ZY, Wu S, Luo WW, Tan B, Wang XY. Relationship between intestinal microbiota and ulcerative colitis: Mechanisms and clinical application of probiotics and fecal microbiota transplantation. World J Gastroenterol. 2018 Jan 7;24(1):5-14. doi: 10.3748/wjg.v24.i1.5.
PubMed 29358877Dai M, Liu Y, Chen W, Buch H, Shan Y, Chang L, Bai Y, Shen C, Zhang X, Huo Y, Huang D, Yang Z, Hu Z, He X, Pan J, Hu L, Pan X, Wu X, Deng B, Li Z, Cui B, Zhang F. Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients. Crit Care. 2019 Oct 21;23(1):324. doi: 10.1186/s13054-019-2604-5.
PubMed 31639033Gu X, Yang Z, Kou Y, Yang F, Wang Y, Chen Y, Wang E, Jiang X, Bai Y, Zhang Z, Zhang S. Effects of Retrograde Colonic Enema-Based Fecal Microbiota Transplantation in the Treatment of Childhood Constipation: A Randomized, Double-Blind, Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2288-2297. doi: 10.14309/ajg.0000000000002958. Epub 2024 Jul 11.
PubMed 38989869
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation
- ClinicalTrials.gov ID
- NCT05035784
- Acronym / sponsor ID
- A333--1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 5 Sep 2021 (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.
Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease.
Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal supernatant | Active comparator | Drug: Fecal supernatantFecal supernatant is used for treatment of childhood Constipation |
| non-Fecal supernatant | Placebo comparator | Drug: PlaceboPlacebo is used for treatment of childhood Constipation |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 4-14 years old;
- Roman IV criteria for childhood constipation;
- After a course of PEG and a course of Chinese medicine treatment was ineffective;
- Barium enema showing fecal impaction.
Key exclusion criteria (7 listed)
- Congenital and/or acquired intestinal diseases, such as congenital megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumors;
- Anorectal diseases, such as anal atresia, fistula, abscess, and tumor;
- Neurological diseases, such as brain and spinal cord diseases;
- genetic metabolic diseases;
- psychosocial and behavioral diseases;
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 |
|---|---|---|
| Fecal supernatantFecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight . | Drug | Fecal supernatant |
| Placeboa placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline. | Drug | non-Fecal supernatant |
Primary outcome
improvement of spontaneous bowel movements(SBMs) per week
Time frame: Baseline
the frequency of defecation without drugs or other auxiliary methods
improvement of spontaneous bowel movements(SBMs) per week
Time frame: at the end of 4-weeks FMT treatment
the frequency of defecation without drugs or other auxiliary methods
improvement of spontaneous bowel movements(SBMs) per week
Time frame: at the end of 12 weeks follow-up
the frequency of defecation without drugs or other auxiliary methods
Satisfaction with bowel function
Time frame: Baseline
Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Satisfaction with bowel function
Time frame: at the end of 4-weeks FMT treatment
Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Satisfaction with bowel function
Time frame: at the end of 12 weeks follow-up
Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
15 secondary outcomes
Bowel movements
Time frame: Baseline
Bowel movements
Time frame: at the end of 4-weeks FMT treatment
Bowel movements
Time frame: at the end of 12 weeks follow-up
Painful or hard bowel movements
Time frame: Baseline
Painful or hard bowel movements
Time frame: at the end of 4-weeks FMT treatment
Painful or hard bowel movements
Time frame: at the end of 12 weeks follow-up
Large diameter or scybalous stools
Time frame: Baseline
Large diameter or scybalous stools
Time frame: at the end of 4-weeks FMT treatment
Large diameter or scybalous stools
Time frame: at the end of 12 weeks follow-up
Excessive volitional stool retention
Time frame: Baseline
Excessive volitional stool retention
Time frame: at the end of 4-weeks FMT treatment
Excessive volitional stool retention
Time frame: at the end of 12 weeks follow-up
Encopresis
Time frame: Baseline
Encopresis
Time frame: at the end of 4-weeks FMT treatment
Encopresis
Time frame: at the end of 12 weeks follow-up
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 22 Nov 2023.
- Background: PubMed 27529553Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.
- Background: PubMed 31169545Gurram B, Sue PK. Fecal microbiota transplantation in children: current concepts. Curr Opin Pediatr. 2019 Oct;31(5):623-629. doi: 10.1097/MOP.0000000000000787.
- Background: PubMed 30908299Xu D, Chen VL, Steiner CA, Berinstein JA, Eswaran S, Waljee AK, Higgins PDR, Owyang C. Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Jul;114(7):1043-1050. doi: 10.14309/ajg.0000000000000198.
- Background: PubMed 26751143Tian H, Ding C, Gong J, Ge X, McFarland LV, Gu L, Wei Y, Chen Q, Zhu W, Li J, Li N. Treatment of Slow Transit Constipation With Fecal Microbiota Transplantation: A Pilot Study. J Clin Gastroenterol. 2016 Nov/Dec;50(10):865-870. doi: 10.1097/MCG.0000000000000472.
- Background: PubMed 30809523Ohkusa T, Koido S, Nishikawa Y, Sato N. Gut Microbiota and Chronic Constipation: A Review and Update. Front Med (Lausanne). 2019 Feb 12;6:19. doi: 10.3389/fmed.2019.00019. eCollection 2019.
- Background: PubMed 31665572Kassam Z, Dubois N, Ramakrishna B, Ling K, Qazi T, Smith M, Kelly CR, Fischer M, Allegretti JR, Budree S, Panchal P, Kelly CP, Osman M. Donor Screening for Fecal Microbiota Transplantation. N Engl J Med. 2019 Nov 21;381(21):2070-2072. doi: 10.1056/NEJMc1913670. Epub 2019 Oct 30. No abstract available.
- Background: PubMed 22002980Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
- Background: PubMed 31690829Vriesman MH, Koppen IJN, Camilleri M, Di Lorenzo C, Benninga MA. Management of functional constipation in children and adults. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):21-39. doi: 10.1038/s41575-019-0222-y. Epub 2019 Nov 5.
- Background: PubMed 27688650Clemente MG, Mandato C, Poeta M, Vajro P. Pediatric non-alcoholic fatty liver disease: Recent solutions, unresolved issues, and future research directions. World J Gastroenterol. 2016 Sep 28;22(36):8078-93. doi: 10.3748/wjg.v22.i36.8078.
- Background: PubMed 28129018Woodworth MH, Carpentieri C, Sitchenko KL, Kraft CS. Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review. Gut Microbes. 2017 May 4;8(3):225-237. doi: 10.1080/19490976.2017.1286006. Epub 2017 Jan 27.
- Background: PubMed 28164849Vindigni SM, Surawicz CM. Fecal Microbiota Transplantation. Gastroenterol Clin North Am. 2017 Mar;46(1):171-185. doi: 10.1016/j.gtc.2016.09.012.
- Background: PubMed 29358877Shen ZH, Zhu CX, Quan YS, Yang ZY, Wu S, Luo WW, Tan B, Wang XY. Relationship between intestinal microbiota and ulcerative colitis: Mechanisms and clinical application of probiotics and fecal microbiota transplantation. World J Gastroenterol. 2018 Jan 7;24(1):5-14. doi: 10.3748/wjg.v24.i1.5.
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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 Fecal supernatant in people with Fecal Microbiota Transplantation and Constipation - Functional, run by Shengjing Hospital at 1 site in China.
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 4 inclusion and 7 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 22 Nov 2023. 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 China. 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.
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?
improvement of spontaneous bowel movements(SBMs) per week (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT05035784, which also lists 14 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 22 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.