Irritable Bowel Syndrome Variant of ChildhoodNCT04890405
Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
A study testing Standardized FMT and Precision Flora Transplantation in people with Irritable Bowel Syndrome Variant of Childhood, run by Yanling Wei.
Trial summary
In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome Variant of Childhood
- What is being tested?
- Standardized FMT and Precision Flora Transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2021to 1 Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 ~ 75 years.
- Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D.
- IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks.
- No other serious diseases, no mental disorders, and normal communication skills.
- Sign informed consent and agree to participate in this study.
- No antibiotics and probiotics were used within one month.
Who cannot join
- Patients are unwilling to participate in this study.
- Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system.
- Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc.
- Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt.
- There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome.
- Patients with various acute infections, tumors, severe arrhythmia, mental system disorders, and drug or alcohol addicts.
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- History of abdominal surgery (except appendicitis, cholecystitis, caesarean section and hysterectomy).
- Those who were allergic to capsule drugs or contraindications.
- Lactose intolerance.
- Clinical researchers who are engaged in other related irritable bowel syndrome at the time of enrollment or within 3 months before enrollment.
- It is difficult to complete the follow-up, or various factors affecting the compliance.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. To observe the similarities and differences of the effect between the two treatment methods on the disease. and the changes in intestinal bacteria was also observed.
Read the detailed description
In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups. The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days. The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection. The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.
- Being tested
- Standardized FMT, Precision Flora Transplantation
- Keywords
- irritable bowel syndrome, diarrhea, Fecal Microbiota Transplantation
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized FMTProcedure or surgery
The group includes 35 patients. They will receive standardized FMT. Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally. It was given only once.
Precision Flora TransplantationCombination product
The group includes 35 patients. They will receive Precision Flora Transplantation. They were used self-developed precision transplant capsules for precision flora transplantation. 4 capsules are used each time. Each capsule contains 400mg of various probiotics effective against diarrhea. It is used orally, once a day,for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Active comparator | Standardized FMT once.Extract all the flora from the feces provided by the donor to make fecal bacteria transplant capsules. The patient took orally on an empty stomach, each time using 3.2g of fecal bacteria. Receives: Procedure: Standardized FMT |
| JZ group | Experimental | 1.6g Po perday,for 28 days. probiotics that are effective against diarrhea were selected to make precise flora capsules, which are taken when the patient is on an empty stomach, once a day, using 1.6 g of bacteria per day, orally for 28 consecutive days. Receives: Combination Product: Precision Flora Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS score
Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.
Measured: 12 Week after treatment
Secondary outcomes (8)
Clinical remission rate
Proportion of people in clinical remission after treatment
Measured: 2、4、8、12 Week after treatment
GSRS score
Gastrointestinal Symptom Rating Scale.The score varies from 16 to 112. Higher scores suggest more severe gastrointestinal pathology.
Measured: 0、2、4、8、12Week after treatment
IBS-QoL score
Quality of life score for IBS patients.The score varies from 0 to 136. Higher scores suggest greater impact of disease on life
Measured: 0、2、4、8、12Week after treatment
PHQ-9
Patient Health Questionnaire-9.The score varies from 0 to 27. Higher scores suggest more severe the depression
Measured: 0、2、4、8、12Week after treatment
GAD-7
Generalized Anxiety Scale-7.The score varies from 0 to 21. Higher scores suggest heavier the anxiety.
Measured: 0、2、4、8、12Week after treatment
SAS
Self-rating Anxiety Scale.The score varies from 25 to 100. Higher scores suggest greater degree of anxiety.
Measured: 0、2、4、8、12Week after treatment
SDS
Self-rating Depression Scale.The score varies from 25 to 100. Higher scores suggest more severe depression.
Measured: 0、2、4、8、12after treatment
Intestinal flora
Use metagenomics technology to detect intestinal flora
Measured: 0、2、4、8、12Week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start20 May 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome Variant of ChildhoodStudies 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
- Model description
- Diarrhea-type irritable bowel syndrome patients were randomly divided into 2 groups, and each group was given a different treatment method
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanling Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanling Wei, Third Military Medical University
- Investigators
- Yanling Wei, Principal investigator, Army Medical Center of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890405
- Sponsor's protocol ID
- TMMU-DP-GI-JZ-001
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT04890405
- Acronym / sponsor ID
- TMMU-DP-GI-JZ-001
- Keywords
- irritable bowel syndrome, diarrhea, Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yanling WeiUniversity, hospital or other
- Study start
- 20 May 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 18 May 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.
In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. To observe the similarities and differences of the effect between the two treatment methods on the disease. and the changes in intestinal bacteria was also observed.
Detailed description
In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups. The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days. The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection. The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Diarrhea-type irritable bowel syndrome patients were randomly divided into 2 groups, and each group was given a different treatment method
| Arm | Type | Receives |
|---|---|---|
| FMT group | Active comparator | Procedure: Standardized FMTStandardized FMT once.Extract all the flora from the feces provided by the donor to make fecal bacteria transplant capsules. The patient took orally on an empty stomach, each time using 3.2g of fecal bacteria. |
| JZ group | Experimental | Combination Product: Precision Flora Transplantation1.6g Po perday,for 28 days. probiotics that are effective against diarrhea were selected to make precise flora capsules, which are taken when the patient is on an empty stomach, once a day, using 1.6 g of bacteria per day, orally for 28 consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 18 ~ 75 years.
- Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D.
- IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks.
- No other serious diseases, no mental disorders, and normal communication skills.
- Sign informed consent and agree to participate in this study.
Key exclusion criteria (12 listed)
- Patients are unwilling to participate in this study.
- Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system.
- Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc.
- Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt.
- There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome.
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 |
|---|---|---|
| Standardized FMTThe group includes 35 patients. They will receive standardized FMT. Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally. It was given only once. | Procedure or surgery | FMT group |
| Precision Flora TransplantationThe group includes 35 patients. They will receive Precision Flora Transplantation. They were used self-developed precision transplant capsules for precision flora transplantation. 4 capsules are used each time. Each capsule contains 400mg of various probiotics effective against diarrhea. It is used orally, once a day,for 28 days. | Combination product | JZ group |
Primary outcome
IBS-SSS score
Time frame: 12 Week after treatment
Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.
8 secondary outcomes
Clinical remission rate
Time frame: 2、4、8、12 Week after treatment
GSRS score
Time frame: 0、2、4、8、12Week after treatment
IBS-QoL score
Time frame: 0、2、4、8、12Week after treatment
PHQ-9
Time frame: 0、2、4、8、12Week after treatment
GAD-7
Time frame: 0、2、4、8、12Week after treatment
SAS
Time frame: 0、2、4、8、12Week after treatment
SDS
Time frame: 0、2、4、8、12after treatment
Intestinal flora
Time frame: 0、2、4、8、12Week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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.
Yanling Wei principal investigator
Army Medical Center of PLA
Questions about this trial
What is this clinical trial studying?
A study testing Standardized FMT and Precision Flora Transplantation in people with Irritable Bowel Syndrome Variant of Childhood, run by Yanling Wei.
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 6 inclusion and 12 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanling Wei (15310354666, lingzi016@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-SSS score (time frame: 12 Week after 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 18 May 2021.