Diarrhea InfectiousCDADNCT05770726
Probiotics Administration Via Colonoscopic Spray and Oral Administration in CDAD Patients
A study testing Probiotics administration in people with Diarrhea Infectious, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Clostridioides difficile (C. difficile) colitis is a common hospital-acquired disease, which increases hospitalization length and the mortality rate. Moreover, refractory or recurrent C. difficile colitis is an emerging disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diarrhea Infectious
- What is being tested?
- Probiotics administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Apr 2023to 31 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged ≥ 20 years who are diagnosed with C. difficile colitis
Who cannot join
- patients are diagnosed with colitis because of other etiologies, such as intestinal Behçet's disease, amoeba or parasitic colitis, Salmonella colitis, lymphoma, E. coli colitis, cytomegalovirus colitis, ischemic colitis, sigmoid-colon cancer, inflammatory bowel diseases (ulcerative colitis or Crohn's disease), solitary rectal ulcer syndrome, radiation colitis
- patients who have contraindications for colonoscopy, including declining or refusal to cooperate
- unstable vital signs
- a diagnosis or highly suspicion of colon rupture
- a high-risk situation for colon perforation such as acute diverticulitis
- toxic megacolon, etc.
- acute myocardial infarct
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, Other (Non U.s.), 704
Hsueh-Chien Chiang, M.D., 2353535, scion456scion@gmail.com
About this study
Official title: The Comparison of the Adjuvant Effect of Probiotics Between Delivery Via Colonoscopic Spray and Oral Administration in Patients With Clostridioides Difficile Colitis Receiving Vancomycin Treatment
Clostridioides difficile (C. difficile) colitis is a common hospital-acquired disease, which increases hospitalization length and the mortality rate. Moreover, refractory or recurrent C. difficile colitis is an emerging disease. The tapering course of oral vancomycin or oral fidaxomicin is current standard treatment for refractory or recurrent C. difficile colitis. Fecal microbiota transplantation (FMT) is an alternative one. However, the tapering course of oral vancomycin needs a 6- to 12-week duration, fidaxomicin is expensive, and FMT is not available in every hospital; therefore, it is needed to develop a new treatment. Evidence has shown that the disturbance with reduced diversity of intestinal microbiota may lead to refractory C. difficile colitis. Besides fecal microbiota transplantation, probiotics administration can also correct the disturbed intestinal microbiota. However, inconsistent efficacy of probiotic administration was reported, which may be attributed to the interference by the gastric acid. Precise delivery of probiotics into the colon by colonoscopy can avoid the destruction by gastric acid, with which a better treatment efficacy is expected. The best regimen for C. difficile colitis should be the one which succeeds on the first attempt. Therefore, this study is aimed toward validating the efficacy and safety of the colonoscopic probiotics-spray.
Patients diagnosed with C. colitis will be enrolled. All patients will accept the standard treatment of oral vancomycin for 14 days. As an adjuvant probiotic administration at the same time, enrolled patients will be randomly assigned to the probiotics-spray (PS) group and the probiotics-oral (PO) group, respectively. The patients in the PS group will receive colonoscopic spray of probiotics once, while the patients in the PO group will receive the same dosage of oral probiotics divided into 5 days. This study will compare the difference in fecal microbiota changes between the colonoscopic probiotics-spray group and the probiotics-oral group. Moreover, this study will evaluate the efficacy and safety between the colonoscopic probiotics-spray and probiotics-oral in patients with C. difficile colitis.
Read the detailed description
Refractory or recurrent C. difficile colitis is an emerging disease. The tapering course of oral vancomycin or oral fidaxomicin is current standard treatment for refractory or recurrent C. difficile colitis.FMT is an alternative treatment. Nevertheless, the tapering course of oral vancomycin needs a 6- to 12-week duration, fidaxomicin is expensive, and FMT is not available in many hospitals. Therefore, we need a method which is effective for patients and available for clinicians.
The disturbance with reduced diversity of intestinal microbiota may lead to refractory or recurrent C. difficile colitis. Moreover, the probiotics administration can correct the disturbed intestinal microbiota. However, inconsistent efficacy of probiotic administration was reported, which may be attributed to the interference by the gastric acid. There is no exact estimation for the amounts of probiotics in the colon after oral administration. Moreover, there is no study which is conducted to compare the efficiency of probiotics between direct spray via colonoscopy and oral administration. It will be novel to study such issue. If the amounts of probiotics which is delivered directly via colonoscopy and the clinical efficacy are similar to those by FMT, colonoscopic probiotics-spray will replace FMT in clinical practice.
FMT can correct the disturbed intestinal microbiota. The estimated bacteria of human wet stool are 1011 per gram. The amount of stool for FMT is ~30 to 100 grams; thus, ~1012 to 1013 bacteria will be transplanted in an FMT procedure. In this project, we will transplant ~2x1011 probiotics into the colon by the colonoscopic spray. Therefore, we believe that colonoscopic spray of probiotics will have similar amounts of bacteria transplanted with FMT but be more efficient than oral probiotics administration.
Probiotics use may have adverse events. There are few studies and case reports which recorded that the administered probiotic was isolated from sterile sites, such as bacteremia. Thus, the safety issue of this study will focus on the adverse events, bacteremia and sepsis.
It will be novel to conduct the study to compare the efficacy and safety of probiotics which are delivered directly via colonoscopy and oral administration. If it works, colonoscopic probiotics spray will replace FMT in clinical practice.
- Conditions
- Diarrhea Infectious
- Being tested
- Probiotics administration
- Keywords
- Clostridioides difficile colitis
- Medical subject headings
- Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics administrationDietary supplement
A total of 10 grams of probiotics was administered in both group, but the routes were different. One group were per colonoscopic spray, and the other was per oral.
| Study group | Role | What they receive |
|---|---|---|
| probiotics-spray (PS) group | Active comparator | In the PS group, the colonoscopic prescription of 10 grams of probiotics powder is performed once on one of the first three days (D0-D3). Receives: Dietary Supplement: Probiotics administration |
| probiotics-oral (PO) group | Active comparator | In the PO group, we will prescribe oral probiotics 2 capsules once per day for 5 days (a total of 10 grams) as adjunctive treatment during the first five days (D0-D4). Receives: Dietary Supplement: Probiotics administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of difference in fecal microbiota change, including probiotics, between the colonoscopic probiotics-spray and probiotics-oral and before and after probiotics use either by colonoscopic probiotics-spray or probiotics-oral
All patients will be monitored for 30 days after diagnosis of C. difficile colitis. The primary endpoint is the comparison of the perseverance of fecal microbiota and metabolites. We will compare the microbiota by sequencing 16S rRNA, measured as percentage abundance per microbial species and differences in percentage abundance between the PS group and PO group in Day 0 and Day 5. We will also compare the relative abundance of C. difficile and target probiotics between the two study groups, such as Lactobacillus acidophilus, Bifidobacterium bifidum, Streptococcus thermophilus, or others.
Measured: 5 days
Secondary outcomes (5)
The rate of resolution of C. difficile colitis
the resolution time of diarrhea and bloody stool
Measured: 30 days
Hospitalization length
the total hospitalization length
Measured: 30 days
The rate of recurrence of C. difficile colitis
the recurrence of C. difficile colitis
Measured: 30 days
The rate of mortality events
all-cause mortality
Measured: 30 days
The rate of adverse events
adverse events from probiotics, including probiotics bacteremia and sepsis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start21 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Diarrhea InfectiousStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsueh-Chien Chiang, M.D., Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770726
- Sponsor's protocol ID
- B-BR-111-052
- Acronym
- CDAD
- Status last verified
- Jan 2024
- First submitted
- 5 Mar 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing after the study completed and the paper published
Publications
McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):e1-e48. doi: 10.1093/cid/cix1085.
PubMed 29462280Bagdasarian N, Rao K, Malani PN. Diagnosis and treatment of Clostridium difficile in adults: a systematic review. JAMA. 2015 Jan 27;313(4):398-408. doi: 10.1001/jama.2014.17103.
PubMed 25626036Kelly CP, LaMont JT. Clostridium difficile--more difficult than ever. N Engl J Med. 2008 Oct 30;359(18):1932-40. doi: 10.1056/NEJMra0707500. No abstract available.
PubMed 18971494Kelly CR, Fischer M, Allegretti JR, LaPlante K, Stewart DB, Limketkai BN, Stollman NH. ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol. 2021 Jun 1;116(6):1124-1147. doi: 10.14309/ajg.0000000000001278.
PubMed 34003176Goodhand JR, Alazawi W, Rampton DS. Systematic review: Clostridium difficile and inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Feb;33(4):428-41. doi: 10.1111/j.1365-2036.2010.04548.x. Epub 2010 Dec 30.
PubMed 21198703Chang JY, Antonopoulos DA, Kalra A, Tonelli A, Khalife WT, Schmidt TM, Young VB. Decreased diversity of the fecal Microbiome in recurrent Clostridium difficile-associated diarrhea. J Infect Dis. 2008 Feb 1;197(3):435-8. doi: 10.1086/525047.
PubMed 18199029Mullish BH, Quraishi MN, Segal JP, McCune VL, Baxter M, Marsden GL, Moore DJ, Colville A, Bhala N, Iqbal TH, Settle C, Kontkowski G, Hart AL, Hawkey PM, Goldenberg SD, Williams HRT. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines. Gut. 2018 Nov;67(11):1920-1941. doi: 10.1136/gutjnl-2018-316818. Epub 2018 Aug 28.
PubMed 30154172van 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 23323867Hemarajata P, Versalovic J. Effects of probiotics on gut microbiota: mechanisms of intestinal immunomodulation and neuromodulation. Ther Adv Gastroenterol. 2013 Jan;6(1):39-51. doi: 10.1177/1756283X12459294.
PubMed 23320049Hempel S, Newberry SJ, Maher AR, Wang Z, Miles JN, Shanman R, Johnsen B, Shekelle PG. Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis. JAMA. 2012 May 9;307(18):1959-69. doi: 10.1001/jama.2012.3507.
PubMed 22570464Phanchana M, Harnvoravongchai P, Wongkuna S, Phetruen T, Phothichaisri W, Panturat S, Pipatthana M, Charoensutthivarakul S, Chankhamhaengdecha S, Janvilisri T. Frontiers in antibiotic alternatives for Clostridioides difficile infection. World J Gastroenterol. 2021 Nov 14;27(42):7210-7232. doi: 10.3748/wjg.v27.i42.7210.
PubMed 34876784Pillai A, Nelson R. Probiotics for treatment of Clostridium difficile-associated colitis in adults. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD004611. doi: 10.1002/14651858.CD004611.pub2.
PubMed 18254055Corcoran BM, Stanton C, Fitzgerald GF, Ross RP. Survival of probiotic lactobacilli in acidic environments is enhanced in the presence of metabolizable sugars. Appl Environ Microbiol. 2005 Jun;71(6):3060-7. doi: 10.1128/AEM.71.6.3060-3067.2005.
PubMed 15933002Han S, Lu Y, Xie J, Fei Y, Zheng G, Wang Z, Liu J, Lv L, Ling Z, Berglund B, Yao M, Li L. Probiotic Gastrointestinal Transit and Colonization After Oral Administration: A Long Journey. Front Cell Infect Microbiol. 2021 Mar 10;11:609722. doi: 10.3389/fcimb.2021.609722. eCollection 2021.
PubMed 33791234Staley C, Halaweish H, Graiziger C, Hamilton MJ, Kabage AJ, Galdys AL, Vaughn BP, Vantanasiri K, Suryanarayanan R, Sadowsky MJ, Khoruts A. Lower endoscopic delivery of freeze-dried intestinal microbiota results in more rapid and efficient engraftment than oral administration. Sci Rep. 2021 Feb 25;11(1):4519. doi: 10.1038/s41598-021-84152-6.
PubMed 33633264
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Adjuvant Effect of Probiotics Between Delivery Via Colonoscopic Spray and Oral Administration in Patients With Clostridioides Difficile Colitis Receiving Vancomycin Treatment
- ClinicalTrials.gov ID
- NCT05770726
- Acronym / sponsor ID
- CDAD / B-BR-111-052
- Conditions
- Diarrhea Infectious
- Keywords
- Clostridioides difficile colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Mar 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.
Clostridioides difficile (C. difficile) colitis is a common hospital-acquired disease, which increases hospitalization length and the mortality rate. Moreover, refractory or recurrent C. difficile colitis is an emerging disease. The tapering course of oral vancomycin or oral fidaxomicin is current standard treatment for refractory or recurrent C. difficile colitis. Fecal microbiota transplantation (FMT) is an alternative one. However, the tapering course of oral vancomycin needs a 6- to 12-week duration, fidaxomicin is expensive, and FMT is not available in every hospital; therefore, it is needed to develop a new treatment. Evidence has shown that the disturbance with reduced diversity of intestinal microbiota may lead to refractory C. difficile colitis. Besides fecal microbiota transplantation, probiotics administration can also correct the disturbed intestinal microbiota. However, inconsistent efficacy of probiotic administration was reported, which may be attributed to the interference by the gastric acid. Precise delivery of probiotics into the colon by colonoscopy can avoid the destruction by gastric acid, with which a better treatment efficacy is expected. The best regimen for C. difficile colitis should be the one which succeeds on the first attempt. Therefore, this study is aimed toward validating the efficacy and safety of the colonoscopic probiotics-spray.
Patients diagnosed with C. colitis will be enrolled. All patients will accept the standard treatment of oral vancomycin for 14 days. As an adjuvant probiotic administration at the same time, enrolled patients will be randomly assigned to the probiotics-spray (PS) group and the probiotics-oral (PO) group, respectively. The patients in the PS group will receive colonoscopic spray of probiotics once, while the patients in the PO group will receive the same dosage of oral probiotics divided into 5 days. This study will compare the difference in fecal microbiota changes between the colonoscopic probiotics-spray group and the probiotics-oral group. Moreover, this study will evaluate the efficacy and safety between the colonoscopic probiotics-spray and probiotics-oral in patients with C. difficile colitis.
Detailed description
Refractory or recurrent C. difficile colitis is an emerging disease. The tapering course of oral vancomycin or oral fidaxomicin is current standard treatment for refractory or recurrent C. difficile colitis.FMT is an alternative treatment. Nevertheless, the tapering course of oral vancomycin needs a 6- to 12-week duration, fidaxomicin is expensive, and FMT is not available in many hospitals. Therefore, we need a method which is effective for patients and available for clinicians.
The disturbance with reduced diversity of intestinal microbiota may lead to refractory or recurrent C. difficile colitis. Moreover, the probiotics administration can correct the disturbed intestinal microbiota. However, inconsistent efficacy of probiotic administration was reported, which may be attributed to the interference by the gastric acid. There is no exact estimation for the amounts of probiotics in the colon after oral administration. Moreover, there is no study which is conducted to compare the efficiency of probiotics between direct spray via colonoscopy and oral administration. It will be novel to study such issue. If the amounts of probiotics which is delivered directly via colonoscopy and the clinical efficacy are similar to those by FMT, colonoscopic probiotics-spray will replace FMT in clinical practice.
FMT can correct the disturbed intestinal microbiota. The estimated bacteria of human wet stool are 1011 per gram. The amount of stool for FMT is ~30 to 100 grams; thus, ~1012 to 1013 bacteria will be transplanted in an FMT procedure. In this project, we will transplant ~2x1011 probiotics into the colon by the colonoscopic spray. Therefore, we believe that colonoscopic spray of probiotics will have similar amounts of bacteria transplanted with FMT but be more efficient than oral probiotics administration.
Probiotics use may have adverse events. There are few studies and case reports which recorded that the administered probiotic was isolated from sterile sites, such as bacteremia. Thus, the safety issue of this study will focus on the adverse events, bacteremia and sepsis.
It will be novel to conduct the study to compare the efficacy and safety of probiotics which are delivered directly via colonoscopy and oral administration. If it works, colonoscopic probiotics spray will replace FMT in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics-spray (PS) group | Active comparator | Dietary Supplement: Probiotics administrationIn the PS group, the colonoscopic prescription of 10 grams of probiotics powder is performed once on one of the first three days (D0-D3). |
| probiotics-oral (PO) group | Active comparator | Dietary Supplement: Probiotics administrationIn the PO group, we will prescribe oral probiotics 2 capsules once per day for 5 days (a total of 10 grams) as adjunctive treatment during the first five days (D0-D4). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged ≥ 20 years who are diagnosed with C. difficile colitis
Key exclusion criteria (7 listed)
- patients are diagnosed with colitis because of other etiologies, such as intestinal Behçet's disease, amoeba or parasitic colitis, Salmonella colitis, lymphoma, E. coli colitis, cytomegalovirus colitis, ischemic colitis, sigmoid-colon cancer, inflammatory bowel diseases (ulcerative colitis or Crohn's disease), solitary rectal ulcer syndrome, radiation colitis
- patients who have contraindications for colonoscopy, including declining or refusal to cooperate
- unstable vital signs
- a diagnosis or highly suspicion of colon rupture
- a high-risk situation for colon perforation such as acute diverticulitis
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 |
|---|---|---|
| Probiotics administrationA total of 10 grams of probiotics was administered in both group, but the routes were different. One group were per colonoscopic spray, and the other was per oral. | Dietary supplement | probiotics-oral (PO) group, probiotics-spray (PS) group |
Primary outcome
The percentage of difference in fecal microbiota change, including probiotics, between the colonoscopic probiotics-spray and probiotics-oral and before and after probiotics use either by colonoscopic probiotics-spray or probiotics-oral
Time frame: 5 days
All patients will be monitored for 30 days after diagnosis of C. difficile colitis. The primary endpoint is the comparison of the perseverance of fecal microbiota and metabolites. We will compare the microbiota by sequencing 16S rRNA, measured as percentage abundance per microbial species and differences in percentage abundance between the PS group and PO group in Day 0 and Day 5. We will also compare the relative abundance of C. difficile and target probiotics between the two study groups, such as Lactobacillus acidophilus, Bifidobacterium bifidum, Streptococcus thermophilus, or others.
5 secondary outcomes
The rate of resolution of C. difficile colitis
Time frame: 30 days
Hospitalization length
Time frame: 30 days
The rate of recurrence of C. difficile colitis
Time frame: 30 days
The rate of mortality events
Time frame: 30 days
The rate of adverse events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Results publication: PubMed 29462280McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):e1-e48. doi: 10.1093/cid/cix1085.
- Results publication: PubMed 25626036Bagdasarian N, Rao K, Malani PN. Diagnosis and treatment of Clostridium difficile in adults: a systematic review. JAMA. 2015 Jan 27;313(4):398-408. doi: 10.1001/jama.2014.17103.
- Results publication: PubMed 18971494Kelly CP, LaMont JT. Clostridium difficile--more difficult than ever. N Engl J Med. 2008 Oct 30;359(18):1932-40. doi: 10.1056/NEJMra0707500. No abstract available.
- Results publication: PubMed 34003176Kelly CR, Fischer M, Allegretti JR, LaPlante K, Stewart DB, Limketkai BN, Stollman NH. ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol. 2021 Jun 1;116(6):1124-1147. doi: 10.14309/ajg.0000000000001278.
- Results publication: PubMed 21198703Goodhand JR, Alazawi W, Rampton DS. Systematic review: Clostridium difficile and inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Feb;33(4):428-41. doi: 10.1111/j.1365-2036.2010.04548.x. Epub 2010 Dec 30.
- Results publication: PubMed 18199029Chang JY, Antonopoulos DA, Kalra A, Tonelli A, Khalife WT, Schmidt TM, Young VB. Decreased diversity of the fecal Microbiome in recurrent Clostridium difficile-associated diarrhea. J Infect Dis. 2008 Feb 1;197(3):435-8. doi: 10.1086/525047.
- Results publication: PubMed 30154172Mullish BH, Quraishi MN, Segal JP, McCune VL, Baxter M, Marsden GL, Moore DJ, Colville A, Bhala N, Iqbal TH, Settle C, Kontkowski G, Hart AL, Hawkey PM, Goldenberg SD, Williams HRT. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines. Gut. 2018 Nov;67(11):1920-1941. doi: 10.1136/gutjnl-2018-316818. Epub 2018 Aug 28.
- 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 23320049Hemarajata P, Versalovic J. Effects of probiotics on gut microbiota: mechanisms of intestinal immunomodulation and neuromodulation. Ther Adv Gastroenterol. 2013 Jan;6(1):39-51. doi: 10.1177/1756283X12459294.
- Results publication: PubMed 22570464Hempel S, Newberry SJ, Maher AR, Wang Z, Miles JN, Shanman R, Johnsen B, Shekelle PG. Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis. JAMA. 2012 May 9;307(18):1959-69. doi: 10.1001/jama.2012.3507.
- Results publication: PubMed 34876784Phanchana M, Harnvoravongchai P, Wongkuna S, Phetruen T, Phothichaisri W, Panturat S, Pipatthana M, Charoensutthivarakul S, Chankhamhaengdecha S, Janvilisri T. Frontiers in antibiotic alternatives for Clostridioides difficile infection. World J Gastroenterol. 2021 Nov 14;27(42):7210-7232. doi: 10.3748/wjg.v27.i42.7210.
- Results publication: PubMed 18254055Pillai A, Nelson R. Probiotics for treatment of Clostridium difficile-associated colitis in adults. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD004611. doi: 10.1002/14651858.CD004611.pub2.
- Individual participant dataSharing planned: Undecided. IPD sharing after the study completed and the paper published
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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.
Hsueh-Chien Chiang, M.D. principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics administration in people with Diarrhea Infectious, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 7 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 16 May 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsueh-Chien Chiang, M.D. (2353535, scion456scion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of difference in fecal microbiota change, including probiotics, between the colonoscopic probiotics-spray and probiotics-oral and before and after probiotics use either by colonoscopic probiotics-spray or probiotics-oral (time frame: 5 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 NCT05770726, which also lists 25 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 16 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.