UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053277 |
|---|---|
| Receipt number | R000060808 |
| Scientific Title | Multiple oral antibiotics therapy for induction and maintenance of ulcerative colitis |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2024/01/05 17:07:42 |
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Basic information
Public title
Multiple oral antibiotics therapy for induction and maintenance of ulcerative colitis
Acronym
Multiple oral antibiotics therapy for induction and maintenance of ulcerative colitis
Scientific Title
Multiple oral antibiotics therapy for induction and maintenance of ulcerative colitis
Scientific Title:Acronym
Multiple oral antibiotics therapy for ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dysbiosis of gut microbiota has recently been one of the therapeutic targets for UC. We have reported the effectiveness of antibiotic combination therapy (ATM therapy) for induction and maintenance of UC. In this study, we aim to investigate the long-term effectiveness of ATM therapy in a larger cohort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the remission rate at 3 months after the completion of ATM therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
amoxicillin 1500 mg t.i.d., tetracycline 1500 mg t.i.d., and metronidazole 750 mg t.i.d.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were eligible if they had an established diagnosis of UC based on endoscopic, clinical and histological feature.
Key exclusion criteria
Exclusion criteria were penicillin allergy, administration of antibiotics agents within 2 weeks of study entry, ongoing biologic therapy, pregnancy, cancer and other serious comorbid illness. Patients who had stool pathogens including Clostridium difficile, Salmonellae, pathogenic Escherichia coli were also excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Ohkusa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Microbiota Research
Zip code
113-0033
Address
405 Ochanomizu KS Building, 3-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
ynishika@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Microbiota Research
Zip code
113-0033
Address
405 Ochanomizu KS Building, 3-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
ynishika@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
320
Results
The compliance rate was 95.7%. The response rate and remission rate were 75.2% and 30.9% at completion, 62.7% and 29.6% at 3 months, 48.2% and 27.7% at 6 months, 37.9% and 24.4% at 9 months, 35.4% and 24.4% at 12 months, respectively. The most frequent adverse events were diarrhea and fever. No life-threatening adverse events were observed during the trial.
Results date posted
| 2024 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 35. Among the participants, 80.1% had moderate or severe symptoms, 48.6% were steroid dependent and 12.5% were steroid resistant.
Participant flow
All patients received ATM therapy, a combination of oral amoxicillin 1500 mg t.i.d., tetracycline 1500 mg t.i.d., and metronidazole 750 mg t.i.d., for 2 weeks either at hospital or at home, together with their conventional treatment. Patients whose symptoms improved only gradually at 2 weeks and were expected to continue their improvement extended the regimen to 4 weeks in total under their physicians decision. The clinical examination was performed at baseline, treatment completion, 3 months, 9 months and 12 months. The total colonoscopy was performed at baseline, at 3 months and at 12 months. All adverse events were recorded.
Adverse events
There were 189 (60.8%) of patients who experienced adverse events. The most frequent symptom was diarrhea (19.0%), followed by fever (14.8%), upper gastrointestinal disorders (9.6%), rash (7.1%), fatigue (6.7%), hypogeusia (4.8%) and headache (4.2%). There was no life-threatening episode during the trial. All the adverse symptoms disappeared immediately after the discontinuation or the completement of the ATM therapy.
Outcome measures
The response rate and remission rate were 75.2% and 30.9% at completion, 62.7% and 29.6% at 3 months, 48.2% and 27.7% at 6 months, 37.9% and 24.4% at 9 months, 35.4% and 24.4% at 12 months, respectively. The most frequent adverse events were diarrhea and fever. No life-threatening adverse events were observed during the trial.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2002 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2001 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2002 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060808
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