Functional ConstipationPhase 4CPIFGDNCT05366335
Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease
A Phase 4 study testing Live Combined Bifidobacterium and Lactobacillus, Normal saline and Basic treatment in people with Functional Constipation and Irritable Bowel Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Constipation, Irritable Bowel Syndrome, Probiotics
- What is being tested?
- Live Combined Bifidobacterium and Lactobacillus, Normal saline and Basic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2022to 1 Jan 2023
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing for colonoscopy
- Meet Rome IV diagnostic criteria for functional constipation or irritable bowel syndrome
- Voluntarily participate in this clinical study and sign the informed consent.
Who cannot join
- Use of probiotics or antibiotics within the past 4 weeks
- History of intestinal surgery
- History of severe liver and kidney disease
- History of cardiovascular and cerebrovascular diseases
- History of neuropsychiatric diseases
- Pregnant women or lactating women
- Allergic to any ingredients of the live bacteria tablet
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yun Feng, 0086-029-85323920, amyyun@xjtu.edu.cn
About this study
Official title: Value of Colonoscopic Probiotics Infusion in Patients With Functional Gastrointestinal Disease: a Prospective Randomized Controlled Study
The purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. The invesitigators will randomize the included study subjects. The experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. The control group receive basic treatment and a single injection of normal saline through colonoscopy. The invesitigators will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. Other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.
- Being tested
- Live Combined Bifidobacterium and Lactobacillus, Normal saline, Basic treatment
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Combined Bifidobacterium and LactobacillusDrug
Also called Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopy
The invesitigators give patients Live Combined Bifidobacterium and Lactobacillus solution infusion during their colonoscopy examination for a single time in the Live Combined Bifidobacterium and Lactobacillus group.
Normal salineDrug
Also called Normal saline as placebo infusion through colonoscopy
The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.
Basic treatmentDrug
The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Live Combined Bifidobacterium and Lactobacillus | Experimental | The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy. Receives: Drug: Live Combined Bifidobacterium and Lactobacillus; Drug: Basic treatment |
| Control | Placebo comparator | The control group receive basic treatment and a single injection of normal saline through colonoscopy. Receives: Drug: Normal saline; Drug: Basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of effective patients with functional constipation and irritable bowel syndrome patients
The efficacy of irritable bowel syndrome is evaluated by stool texture and abdominal discomfort related scales including IBS-SSS, BSS score, IBS-QOL,HADS and number of bowel movements per day in 12 weeks after start of treatment. The efficacy of functional constipation is evaluated by weekly defecation frequency, spontaneous complete bowel movement, and scales such as Wexner constipation score, BSS score, and PAC-QOL in 8 weeks after start of treatment.
Measured: 8-12 weeks after start of treatment.
Secondary outcomes (1)
Incidence of adverse events related to treatment
The safety of single colonoscopic probiotics infusion was evaluated by incidence of adverse events related to colonoscopic probiotics infusion during the treatment and 8-12 weeks after the treatment.
Measured: 8-12 weeks after start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start4 Jul 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Feng, M.D., Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366335
- Sponsor's protocol ID
- XJTU1AF2022LSK-205
- Acronym
- CPIFGD
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Colonoscopic Probiotics Infusion in Patients With Functional Gastrointestinal Disease: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05366335
- Acronym / sponsor ID
- CPIFGD / XJTU1AF2022LSK-205
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 May 2022 (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 purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. The invesitigators will randomize the included study subjects. The experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. The control group receive basic treatment and a single injection of normal saline through colonoscopy. The invesitigators will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. Other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Combined Bifidobacterium and Lactobacillus | Experimental | Drug: Live Combined Bifidobacterium and Lactobacillus, Drug: Basic treatmentThe experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy. |
| Control | Placebo comparator | Drug: Normal saline, Drug: Basic treatmentThe control group receive basic treatment and a single injection of normal saline through colonoscopy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing for colonoscopy
- Meet Rome IV diagnostic criteria for functional constipation or irritable bowel syndrome
- Voluntarily participate in this clinical study and sign the informed consent.
Key exclusion criteria (7 listed)
- Use of probiotics or antibiotics within the past 4 weeks
- History of intestinal surgery
- History of severe liver and kidney disease
- History of cardiovascular and cerebrovascular diseases
- History of neuropsychiatric 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 |
|---|---|---|
| Live Combined Bifidobacterium and LactobacillusAlso: Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopyThe invesitigators give patients Live Combined Bifidobacterium and Lactobacillus solution infusion during their colonoscopy examination for a single time in the Live Combined Bifidobacterium and Lactobacillus group. | Drug | Live Combined Bifidobacterium and Lactobacillus |
| Normal salineAlso: Normal saline as placebo infusion through colonoscopyThe invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group. | Drug | Control |
| Basic treatmentThe invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment. | Drug | Control, Live Combined Bifidobacterium and Lactobacillus |
Primary outcome
Proportion of effective patients with functional constipation and irritable bowel syndrome patients
Time frame: 8-12 weeks after start of treatment.
The efficacy of irritable bowel syndrome is evaluated by stool texture and abdominal discomfort related scales including IBS-SSS, BSS score, IBS-QOL,HADS and number of bowel movements per day in 12 weeks after start of treatment. The efficacy of functional constipation is evaluated by weekly defecation frequency, spontaneous complete bowel movement, and scales such as Wexner constipation score, BSS score, and PAC-QOL in 8 weeks after start of treatment.
1 secondary outcome
Incidence of adverse events related to treatment
Time frame: 8-12 weeks after start of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- 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.
Yun Feng, M.D. study chair
First Affiliated Hospital Xi'an Jiaotong University
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 Live Combined Bifidobacterium and Lactobacillus, Normal saline and Basic treatment in people with Functional Constipation and Irritable Bowel Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University 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 3 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Feng, M.D. (0086-029-85323920, amyyun@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of effective patients with functional constipation and irritable bowel syndrome patients (time frame: 8-12 weeks after start of treatment.). 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 4 Aug 2022.