Intestinal Pseudo-ObstructionFMT-CIPNCT06020365
Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients
A study testing sequential fecal microbiota transplant combined with small intestinal fluid transplant in people with Intestinal Pseudo-Obstruction and Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intestinal Pseudo-Obstruction, Fecal Microbiota Transplantation
- What is being tested?
- sequential fecal microbiota transplant combined with small intestinal fluid transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Aug 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 18 years old;
- met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;
- can tolerate nasojejunal tube and complete full course of FMT treatment;
- the clinical data are relatively complete and there is follow-up available for evaluation
Who cannot join
- accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
- associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients
Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.
- Being tested
- sequential fecal microbiota transplant combined with small intestinal fluid transplant
- Medical subject headings
- Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential fecal microbiota transplant combined with small intestinal fluid transplantOther
for eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| sequential antibiotics treatment and fecal + small intestinal microbiota transplant | Experimental | Not described Receives: Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral Nutrition Tolerance
the maximal amount of enteral nutrition allowed daily
Measured: 8 weeks
Secondary outcomes (1)
Nutrition Status
intersectional muscle and fat area measurements by quantitative computed tomography
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 posted31 Aug 2023
- Study start1 Jan 2018
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Pseudo-ObstructionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020365
- Sponsor's protocol ID
- FMT_CIPO
- Acronym
- FMT-CIP
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients
- ClinicalTrials.gov ID
- NCT06020365
- Acronym / sponsor ID
- FMT-CIP / FMT_CIPO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 Aug 2023 (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.
Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sequential antibiotics treatment and fecal + small intestinal microbiota transplant | Experimental | Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged over 18 years old;
- met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;
- can tolerate nasojejunal tube and complete full course of FMT treatment;
- the clinical data are relatively complete and there is follow-up available for evaluation
Key exclusion criteria (2 listed)
- accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
- associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
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 |
|---|---|---|
| sequential fecal microbiota transplant combined with small intestinal fluid transplantfor eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days. | Other | sequential antibiotics treatment and fecal + small intestinal microbiota transplant |
Primary outcome
Enteral Nutrition Tolerance
Time frame: 8 weeks
the maximal amount of enteral nutrition allowed daily
1 secondary outcome
Nutrition Status
Time frame: 52 weeks
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 31 Aug 2023.
- Individual participant dataSharing planned: Yes
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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 sequential fecal microbiota transplant combined with small intestinal fluid transplant in people with Intestinal Pseudo-Obstruction and Fecal Microbiota Transplantation, run by Shanghai 10th People's 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 2 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 31 Aug 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. 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?
Enteral Nutrition Tolerance (time frame: 8 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 31 Aug 2023.