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Irritable Bowel SyndromePhase 2/3NCT03613545

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

A Phase 2/3 study testing fecal microbiota transplantation and probiotics, antibiotics or antidepressants in people with Irritable Bowel Syndrome and Fecal Microbiota Transplantation, run by Guangzhou First People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
fecal microbiota transplantation and probiotics, antibiotics or antidepressants
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
10 Aug 2018to 31 Dec 2030
Phase
Phase 2/3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be considered eligible for enrolment into the study, subjects must:
  • Be able to give written informed consent.
  • Males and females aged >18 and <75
  • Have IBS as defined by the Rome IV criteria

Who cannot join

  • Subjects will be excluded from the study if they meet any of the below criteria:
  • pregnant or having a follow-up of less than 6 months;
  • unable to give informed consent;
  • suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
  • unable to undergo endoscopy.

Trial locations and contacts

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

Hongli Huang, MM contact

86-13631316718

honglisums@126.com

Huiting Chen, MM contact

86-13926055294

gracy1977@tom.com

China1 site, 1 recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

    Hongli Huang, MM, 86-13631316718, honglisums@126.com

    Huiting chen, MM, 86-13926055294, gracy1977@tom.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.

Read the detailed description

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.

Being tested
fecal microbiota transplantation, Infusion of sham, probiotics, antibiotics or antidepressants
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.

  • fecal microbiota transplantationProcedure or surgery

    200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon

  • Infusion of shamProcedure or surgery

    Infusion of sham

  • probiotics, antibiotics or antidepressantsDrug

    Also called rifaximin, Clostridium butyricum TO-A

    Drugs such as probiotics, antibiotics, antidepressants

Study groups in NCT03613545
Study groupRoleWhat they receive
fecal microbiota transplantationExperimentalfecal microbiota transplantation
Receives: Procedure: fecal microbiota transplantation
placebo fecal microbiota transplantationSham comparatorInfusion of sham
Receives: Procedure: Infusion of sham
Traditional treatmentsSham comparatorTraditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants
Receives: Drug: probiotics, antibiotics or antidepressants

What is being measured

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

  1. Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS)

    This questionnaire was used for assessing IBS severity. Scores of five questions were calculated with the Visual Analogue Scale (VAS) scale: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits and interference with quality of life. The scores ranged from 0 to 500, a higher score indicating worse condition :<75 indicated remission; 75-175 indicated mild IBS;176-300 indicated moderate IBS; and > 300 indicated severe IBS .

    Measured: baseline; one month;three months;six months

Secondary outcomes (2)

  1. Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores

    The IBS-QOL questionnaire consisted of 34 items, covering eight aspects (dysphoria, interference with activity, body image, health worry, food avoidance,social reaction, sexual dysfunction, and relationships). Each item was rated on a 5-point Likert scale(1 = not at all, 5 = a great deal). Total scores were transformed to a 0±100 scale ranging from 0 (maximum quality of life) to 100 (poor quality of life).

    Measured: baseline; one month;three months;six months

  2. Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA)

    The Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) were used to evaluate the mental and psychological states of patients. HAMD scores were graded as follows: 8-19, mild depression; 20-34, moderate depression; ≥35, severely depression. HAMA scores were graded as follows: 14-20, mild anxiety; 21-28, moderate anxiety;≥29 , severe anxiety.

    Measured: baseline; one month;three months;six months

Timeline

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

  1. First posted3 Aug 2018
  2. Study start10 Aug 2018
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03613545
Sponsor's protocol ID
K-2017-078-02
Status last verified
Jul 2021
First submitted
27 Jul 2018
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Distrutti E, Monaldi L, Ricci P, Fiorucci S. Gut microbiota role in irritable bowel syndrome: New therapeutic strategies. World J Gastroenterol. 2016 Feb 21;22(7):2219-41. doi: 10.3748/wjg.v22.i7.2219.

    PubMed 26900286

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing fecal microbiota transplantation and probiotics, antibiotics or antidepressants in people with Irritable Bowel Syndrome and Fecal Microbiota Transplantation, run by Guangzhou First 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 5 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: looking for participants now, as of the sponsor's last update on 3 Aug 2021. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hongli Huang, MM (86-13631316718, honglisums@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS) (time frame: baseline; one month;three months;six months). 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 NCT03613545, which also lists 1 linked publication.

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 3 Aug 2021.

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