Chronic ConstipationNCT06427863

Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation

A study testing Ornidazole in people with Chronic Constipation, run by Faming Zhang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Constipation
What is being tested?: Ornidazole
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteChina
Study dates: Jun 2024to 31 Dec 2029
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet all of the following inclusion criteria to enter the study:
Male and female, aged ≥18 years old, provided written informed consent;
Subjects diagnosed with chronic constipation, with a duration of at least 6 months, and with the following conditions:
1) spontaneous bowel movement frequency <3 times/week (spontaneous bowel movement was defined as spontaneous bowel movement without rescue laxatives or manual assistance); 2) waste hard: at least 25% of defecation in Bristol stool traits scale type 1 or 2.
3. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study.

Who cannot join

Subjects meeting any of the following exclusion criteria must be excluded fromthe study:
Presence of outlet obstruction and constipation, such as rectal mucosal prolapse
Combined with the results of colonoscopy in the past 24 months, those with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.) and constipation;
Constipation caused by other systemic diseases involving the digestive tract, such as nervous system diseases (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.), muscle diseases (such as amyloidosis, dermatomyositis, etc.), mental disorders (such as depression, etc.), metabolic and endocrine disorders (such as diabetes, hypothyroidism, etc.) or opioids, etc.
Has a history of abdominal pelvic surgery, but after cystic resection, cesarean section, does not appear after appendectomy postoperative intestinal complications, and intestinal polyps except after treatment;
Has a history of major surgery within 3 months or a history of severe trauma, and recovery is not completely;

Show all 27Show fewer

There are contraindications to colonic transendoscopic intestinal tube implantation, such as severe intestinal stenosis, obstruction, deep ulcer, and high risk of operation perforation; Severe ulcers or a large number of pseudopolyps exist in the fixed area of titanium clips, which are not suitable for fixation. The subjects' behavior was seriously uncontrolled.
Any of the following abnormalities in cardiac function and performance:
According to the New York Heart Association (NYHA) cardiac function classification, cardiac function grade Ⅲ or above;
new onset myocardial infarction or unstable angina pectoris within 6 months;
ECG showed QTc prolongation (QTc≥ 450ms in men and ≥470ms in women);
Drug-refractory atrial arrhythmias and drug-refractory ventricular arrhythmias (including grade 2 or higher atrioventricular block).
Patients with poor lung function that is considered by the investigator to have an impact on the study treatment, such as patients with acute exacerbation of COPD or patients requiring long-term use of oral or intravenous steroids for control (except inhalers/sprays);
No control autoimmune disease and/or need long-term use of hormone (except local external use sex);
Patients with metabolic diseases and poorly controlled by drugs (such as thyroid dysfunction), or patients with metabolic diseases accompanied by gastrointestinal function complications (such as gastrointestinal autonomic nerve dysfunction, diabetic gastroparesis, etc.);
Suffering from reproductive system diseases (including but not limited to ovarian cysts, endometriosis, primary dysmenorrhea, etc.) that may lead to abdominal pain;
Significant laboratory abnormalities that, in the judgment of the investigator, may affect the safety of the subjects or the completion of the clinical study, including:
the hemoglobin < 100 g/L; B) Serum creatinine ≥1.5 times the upper limit of normal (ULN) C) abnormal liver function, defined as AST>1.5×ULN and/or ALT>1.5×ULN and/or total bilirubin >1.5×ULN; D) blood clotting function: PLT acuities were 80 x 109 / L, APTT > 1.5 x ULN, PT > 1.5 x ULN, INR > 1.5 x ULN; E) abnormal results or defecate occult blood stool and has prompted the clinical significance of the gastrointestinal tract.
Have active hepatitis (requiring or taking long-term treatment), HIV, or active tuberculosis;
A history of drug or alcohol abuse (i.e., drinking more than 14 servings per week of beer, 45 mL of 40% spirits, or 150 mL of wine) or substance abuse;
The known allergic to research similar drugs, drugs or accessories;
Use of anti-infective drugs (antibiotics, antifungal, antiviral) within 14 days before enrollment, or need anti-infective treatment at enrollment evaluation;
Drugs and supplements that affect gastrointestinal motility and function cannot be stopped during the study, including but not limited to: antibiotics such as erythromycin; Drugs that modulate the intestinal microecology, such as probiotics such as Bifidobacterium; The parasympathetic nerve inhibitors, some scopolamine and atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta; Opioid preparations; Drugs that inhibit gastric acid secretion;
Pregnant or lactating women, or refusing to use an effective contraceptive method within 3 months after the last dose of treatment;
3 months prior to dosing involved in drug interventional clinical trials;
Suffering from malignant tumors;
There were other circumstances that the investigator considered inappropriate for participating in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Faming Zhang, PhD contact

Bota Cui contact

China1 site

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011

Other trials in China

About this study

Official title: Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation in Adults: a Multi-center, Randomized, Placebo-controlled Clinical Study

Read the detailed description

All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, complete spontaneous bowel movements（CSBM), Constipation assessment scale (CAS), Patient-Assessment of Constipation Quality Of Life（PAC-QOL) and clinical outcomes were collected. After the treatment, the efficacy and safety were evaluated during the follow-up period.

Conditions: Chronic Constipation
Being tested: Ornidazole, Placebo
Keywords: chronic constipation, washed microbiota transplantation, antibiotic pretreatment, randomized controlled trial, transendoscopic enteral tube

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OrnidazoleDrug
Also called washed microbiota transplantation
Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days
PlaceboDrug
Also called washed microbiota transplantation
Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days

Study groups in NCT06427863
Study group	Role	What they receive
Treatment	Experimental	Patients will receive three enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT once daily for a duration of 3 days. Receives: Drug: Ornidazole
Control	Placebo comparator	Patients will receive three enemas of a placebo of equal volume through the TET tube, followed by WMT once daily for a duration of 3 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Response rate of complete spontaneous bowel movements（CSBM）
Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance.
Measured: One-week, Four-week and Eight-week post-WMT
The extent of change observed in Constipation assessment scale (CAS) of participants
The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation.
Measured: One-week, Four-week and Eight-week post-WMT
The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants
The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks.
Measured: One-week, Four-week and Eight-week post-WMT

Secondary outcomes (2)

The extent of change observed in stool properties of participants
Bristol stool form scale(BSFS) was used, which can be divided into seven types.
Measured: One-week post-WMT
Rate of Adverse Events
The rate of adverse events after antibiotic pretreatment
Measured: One-week, Four-week and Eight-week post-WMT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 202431 Dec 2029

First posted24 May 2024
Study startJun 2024 (estimated)
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Chronic 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06427863
Sponsor's protocol ID: WMT-Anti-CC-202405
Status last verified: May 2024
First submitted: 20 May 2024
Last updated: 24 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Keshteli AH, Millan B, Madsen KL. Pretreatment with antibiotics may enhance the efficacy of fecal microbiota transplantation in ulcerative colitis: a meta-analysis. Mucosal Immunol. 2017 Mar;10(2):565-566. doi: 10.1038/mi.2016.123. Epub 2016 Dec 21. No abstract available.
PubMed 28000680
Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
PubMed 35014601
Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5.
PubMed 16169298
Bazzocchi G, Giovannini T, Giussani C, Brigidi P, Turroni S. Effect of a new synbiotic supplement on symptoms, stool consistency, intestinal transit time and gut microbiota in patients with severe functional constipation: a pilot randomized double-blind, controlled trial. Tech Coloproctol. 2014 Oct;18(10):945-53. doi: 10.1007/s10151-014-1201-5. Epub 2014 Aug 5.
PubMed 25091346
Xu J, Xu H, Guo X, Zhao H, Wang J, Li J, He J, Huang H, Huang C, Zhao C, Li Y, Zhou Y, Peng Y, Nie Y. Pretreatment with an antibiotics cocktail enhances the protective effect of probiotics by regulating SCFA metabolism and Th1/Th2/Th17 cell immune responses. BMC Microbiol. 2024 Mar 18;24(1):91. doi: 10.1186/s12866-024-03251-2.
PubMed 38500062

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation in Adults: a Multi-center, Randomized, Placebo-controlled Clinical Study
ClinicalTrials.gov ID: NCT06427863
Acronym / sponsor ID: WMT-Anti-CC-202405
Conditions: Chronic Constipation
Keywords: chronic constipation, washed microbiota transplantation, antibiotic pretreatment, randomized controlled trial, transendoscopic enteral tube
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 96 participants (estimated)
Lead sponsor: Faming ZhangUniversity, hospital or other
Study start: Jun 2024 (estimated)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 24 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Drug: OrnidazolePatients will receive three enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT once daily for a duration of 3 days.
Control	Placebo comparator	Drug: PlaceboPatients will receive three enemas of a placebo of equal volume through the TET tube, followed by WMT once daily for a duration of 3 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female, aged ≥18 years old, provided written informed consent;
Subjects diagnosed with chronic constipation, with a duration of at least 6 months, and with the following conditions:
1) spontaneous bowel movement frequency <3 times/week (spontaneous bowel movement was defined as spontaneous bowel movement without rescue laxatives or manual assistance); 2) waste hard: at least 25% of defecation in Bristol stool traits scale type 1 or 2.
3. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study.

Key exclusion criteria (27 listed)

Presence of outlet obstruction and constipation, such as rectal mucosal prolapse
Combined with the results of colonoscopy in the past 24 months, those with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.) and constipation;
Constipation caused by other systemic diseases involving the digestive tract, such as nervous system diseases (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.), muscle diseases (such as amyloidosis, dermatomyositis, etc.), mental disorders (such as depression, etc.), metabolic and endocrine disorders (such as diabetes, hypothyroidism, etc.) or opioids, etc.
Has a history of abdominal pelvic surgery, but after cystic resection, cesarean section, does not appear after appendectomy postoperative intestinal complications, and intestinal polyps except after treatment;
Has a history of major surgery within 3 months or a history of severe trauma, and recovery is not completely;

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
OrnidazoleAlso: washed microbiota transplantationPatients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days	Drug	Treatment
PlaceboAlso: washed microbiota transplantationPatients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days	Drug	Control

Primary outcome

Response rate of complete spontaneous bowel movements（CSBM）
Time frame: One-week, Four-week and Eight-week post-WMT
Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance.
The extent of change observed in Constipation assessment scale (CAS) of participants
Time frame: One-week, Four-week and Eight-week post-WMT
The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation.
The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants
Time frame: One-week, Four-week and Eight-week post-WMT
The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks.

2 secondary outcomes

The extent of change observed in stool properties of participants
Time frame: One-week post-WMT
Rate of Adverse Events
Time frame: One-week, Four-week and Eight-week post-WMT

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 24 May 2024.
Background: PubMed 28000680Keshteli AH, Millan B, Madsen KL. Pretreatment with antibiotics may enhance the efficacy of fecal microbiota transplantation in ulcerative colitis: a meta-analysis. Mucosal Immunol. 2017 Mar;10(2):565-566. doi: 10.1038/mi.2016.123. Epub 2016 Dec 21. No abstract available.
Background: PubMed 35014601Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
Background: PubMed 16169298Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5.
Background: PubMed 25091346Bazzocchi G, Giovannini T, Giussani C, Brigidi P, Turroni S. Effect of a new synbiotic supplement on symptoms, stool consistency, intestinal transit time and gut microbiota in patients with severe functional constipation: a pilot randomized double-blind, controlled trial. Tech Coloproctol. 2014 Oct;18(10):945-53. doi: 10.1007/s10151-014-1201-5. Epub 2014 Aug 5.
Background: PubMed 38500062Xu J, Xu H, Guo X, Zhao H, Wang J, Li J, He J, Huang H, Huang C, Zhao C, Li Y, Zhou Y, Peng Y, Nie Y. Pretreatment with an antibiotics cocktail enhances the protective effect of probiotics by regulating SCFA metabolism and Th1/Th2/Th17 cell immune responses. BMC Microbiol. 2024 Mar 18;24(1):91. doi: 10.1186/s12866-024-03251-2.
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.

Faming Zhang, PhD contact

Bota Cui contact

Faming Zhang, PhD principal investigator

The Second Hospital of Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ornidazole in people with Chronic Constipation, run by Faming Zhang 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 5 inclusion and 27 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: opening soon, as of the sponsor's last update on 24 May 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 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?

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 Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of complete spontaneous bowel movements（CSBM） (time frame: One-week, Four-week and Eight-week post-WMT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06427863, which also lists 5 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 24 May 2024.