Clostridium Difficile InfectionNCT03804736
Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection
A study testing FMT-c and FMT-c Lactobacillus in people with Clostridium Difficile Infection, run by Universidad Autonoma de Nuevo Leon.
Trial summary
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- FMT-c and FMT-c Lactobacillus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Dec 2019
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Older than 18 years With recurrent CDI
Who cannot join
- -
About this study
Official title: Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection
Read the detailed description
Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection.
From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.
- Conditions
- Clostridium Difficile Infection
- Being tested
- FMT-c, FMT-c Lactobacillus
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT-cBiological
Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)
FMT-c LactobacillusBiological
Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
| Study group | Role | What they receive |
|---|---|---|
| FMT-c | Active comparator | Patients in this arm received FMT-c (15 capsules every 12 h for 2 days) Receives: Biological: FMT-c |
| FMT-c lactobacillus | Experimental | Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days) Receives: Biological: FMT-c Lactobacillus |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in the number of evacuations
The cure of CDI was measured
Measured: up to two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Nov 2016
- Primary completion30 Jun 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Camacho-Ortiz, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804736
- Sponsor's protocol ID
- IF-0016-3
- Status last verified
- Mar 2019
- First submitted
- 11 Jan 2019
- Last updated
- 5 Mar 2019
- 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 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT03804736
- Acronym / sponsor ID
- IF-0016-3
- Conditions
- Clostridium Difficile Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 1 Nov 2016
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 15 Jan 2019 (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.
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection
Detailed description
Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection.
From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT-c | Active comparator | Biological: FMT-cPatients in this arm received FMT-c (15 capsules every 12 h for 2 days) |
| FMT-c lactobacillus | Experimental | Biological: FMT-c LactobacillusPatients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days) |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Older than 18 years With recurrent CDI
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| FMT-cPatients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days) | Biological | FMT-c |
| FMT-c LactobacillusPatients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days) | Biological | FMT-c lactobacillus |
Primary outcome
decrease in the number of evacuations
Time frame: up to two days
The cure of CDI was measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing FMT-c and FMT-c Lactobacillus in people with Clostridium Difficile Infection, run by Universidad Autonoma de Nuevo Leon.
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 1 inclusion and 1 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 5 Mar 2019. 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?
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?
decrease in the number of evacuations (time frame: up to two days). 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 5 Mar 2019.