Clostridium DifficilePhase 2NCT02857582
Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
A Phase 2 study testing Cultured human intestinal microbiota, Vancomycin and Metronidazole in people with Clostridium Difficile, run by Per Hellström at 1 site in Sweden.
Trial summary
Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Cultured human intestinal microbiota, Vancomycin and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to 1 Dec 2018
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Antibiotic-induced diarrhea
- Positive fecal analysis for Clostridium difficile toxin
Who cannot join
- Antibiotic treatment
- Probiotic treatment
- Intestinal infection other than Clostridium difficile
- Inflammatory bowel disease (Ulcerative colitis, Crohn's disease
- Immunodeficiency (drug- och disease-related)
- Pregnancy
- Unable to accept endoscopic procedures
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.
- Conditions
- Clostridium Difficile
- Being tested
- Cultured human intestinal microbiota, Vancomycin, Metronidazole
- Keywords
- Antibiotic-induced diarrhea, Clostridium-difficile toxin, Pseudomembranous colitis
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured human intestinal microbiotaBiological
Also called Anaerobic cultured human intestinal microbiota (ACHIM)
Secondary treatment for C diff in replacement for regular vancomycin.
VancomycinDrug
Active comparator to treatment with ACHIM
MetronidazoleDrug
Primary treatment for C diff in all treatment arms
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Active comparator | Secondary treatment for relapse of Clostridium difficile infection. Receives: Drug: Vancomycin; Drug: Metronidazole |
| Cultured human intestinal microbiota1 | Experimental | Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection. Receives: Biological: Cultured human intestinal microbiota; Drug: Metronidazole |
| Cultured human intestinal microbiota2 | Experimental | Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection. Receives: Biological: Cultured human intestinal microbiota; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of stool consistency
Normalization according to Bristol stool scale
Measured: 90 days
Secondary outcomes (1)
Normalization of stool frequency
Normalization to less than three bowel movements per day
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Hellström
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Region Gävleborg
- Responsible party
- Sponsor-investigator, Per Hellström, Uppsala University
- Investigators
- Hellström M Per, MD, PhD, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857582
- Sponsor's protocol ID
- ACHIM 1
- Status last verified
- Jan 2019
- First submitted
- 26 Jul 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.
PubMed 21871249Husebye E, Hellstrom PM, Sundler F, Chen J, Midtvedt T. Influence of microbial species on small intestinal myoelectric activity and transit in germ-free rats. Am J Physiol Gastrointest Liver Physiol. 2001 Mar;280(3):G368-80. doi: 10.1152/ajpgi.2001.280.3.G368.
PubMed 11171619Gustafsson A, Berstad A, Lund-Tonnesen S, Midtvedt T, Norin E. The effect of faecal enema on five microflora-associated characteristics in patients with antibiotic-associated diarrhoea. Scand J Gastroenterol. 1999 Jun;34(6):580-6. doi: 10.1080/003655299750026038.
PubMed 10440607Gustafsson A, Lund-Tonnesen S, Berstad A, Midtvedt T, Norin E. Faecal short-chain fatty acids in patients with antibiotic-associated diarrhoea, before and after faecal enema treatment. Scand J Gastroenterol. 1998 Jul;33(7):721-7. doi: 10.1080/00365529850171666.
PubMed 9712236
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
- ClinicalTrials.gov ID
- NCT02857582
- Acronym / sponsor ID
- ACHIM 1
- Conditions
- Clostridium Difficile
- Keywords
- Antibiotic-induced diarrhea, Clostridium-difficile toxin, Pseudomembranous colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Per HellströmUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Region Gävleborg
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Active comparator | Drug: Vancomycin, Drug: MetronidazoleSecondary treatment for relapse of Clostridium difficile infection. |
| Cultured human intestinal microbiota1 | Experimental | Biological: Cultured human intestinal microbiota, Drug: MetronidazoleCultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection. |
| Cultured human intestinal microbiota2 | Experimental | Biological: Cultured human intestinal microbiota, Drug: MetronidazoleCultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Antibiotic-induced diarrhea
- Positive fecal analysis for Clostridium difficile toxin
Key exclusion criteria (8 listed)
- Antibiotic treatment
- Probiotic treatment
- Intestinal infection other than Clostridium difficile
- Inflammatory bowel disease (Ulcerative colitis, Crohn's disease
- Immunodeficiency (drug- och disease-related)
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 |
|---|---|---|
| Cultured human intestinal microbiotaAlso: Anaerobic cultured human intestinal microbiota (ACHIM)Secondary treatment for C diff in replacement for regular vancomycin. | Biological | Cultured human intestinal microbiota1, Cultured human intestinal microbiota2 |
| VancomycinActive comparator to treatment with ACHIM | Drug | Vancomycin |
| MetronidazolePrimary treatment for C diff in all treatment arms | Drug | Cultured human intestinal microbiota1, Cultured human intestinal microbiota2, Vancomycin |
Primary outcome
Normalization of stool consistency
Time frame: 90 days
Normalization according to Bristol stool scale
1 secondary outcome
Normalization of stool frequency
Time frame: 90 days
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 9 Jan 2019.
- Results publication: PubMed 23323867van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Results publication: PubMed 21871249Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24.
- Results publication: PubMed 11171619Husebye E, Hellstrom PM, Sundler F, Chen J, Midtvedt T. Influence of microbial species on small intestinal myoelectric activity and transit in germ-free rats. Am J Physiol Gastrointest Liver Physiol. 2001 Mar;280(3):G368-80. doi: 10.1152/ajpgi.2001.280.3.G368.
- Results publication: PubMed 10440607Gustafsson A, Berstad A, Lund-Tonnesen S, Midtvedt T, Norin E. The effect of faecal enema on five microflora-associated characteristics in patients with antibiotic-associated diarrhoea. Scand J Gastroenterol. 1999 Jun;34(6):580-6. doi: 10.1080/003655299750026038.
- Results publication: PubMed 9712236Gustafsson A, Lund-Tonnesen S, Berstad A, Midtvedt T, Norin E. Faecal short-chain fatty acids in patients with antibiotic-associated diarrhoea, before and after faecal enema treatment. Scand J Gastroenterol. 1998 Jul;33(7):721-7. doi: 10.1080/00365529850171666.
- 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.
Hellström M Per, MD, PhD study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cultured human intestinal microbiota, Vancomycin and Metronidazole in people with Clostridium Difficile, run by Per Hellström at 1 site in Sweden.
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 2 inclusion and 8 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 9 Jan 2019. 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 Sweden. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Normalization of stool consistency (time frame: 90 days). 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 NCT02857582, which also lists 5 linked publications.
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 9 Jan 2019.