UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047319 |
|---|---|
| Receipt number | R000053973 |
| Scientific Title | Wheat Bran Retention Enema as Adjuvant Therapy in children with Lower Respiratory Tract Infection |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/11/12 03:13:08 |
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Basic information
Public title
Wheat Bran Retention Enema as Adjuvant Therapy in children with Lower Respiratory Tract Infection
Acronym
Wheat bran enema in infants with Lower respiratory tract infection
Scientific Title
Wheat Bran Retention Enema as Adjuvant Therapy in children with Lower Respiratory Tract Infection
Scientific Title:Acronym
Wheat bran enema in infants with Lower respiratory tract infection
Region
| Africa |
Condition
Condition
Lower respiratory tract infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this work, we aimed to assess microparticle profiles, inflammatory and anti-inflammatory cytokine profiles in pediatric patients with CAP. Also, we aimed to assess the effect of the use of wheat bran retention enema on microparticle profile and inflammatory and anti-inflammatory cytokine profile in CAP to investigate the role of wheat bran as adjuvant therapy in the management of pediatric patients with CAP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
In this work, we aimed to assess microparticle profiles, inflammatory and anti-inflammatory cytokine profiles in pediatric patients with CAP. Also, we aimed to assess the effect of the use of wheat bran retention enema on microparticle profile and inflammatory and anti-inflammatory cytokine profile in CAP to investigate the role of wheat bran as adjuvant therapy in the management of pediatric patients with CAP.
Key secondary outcomes
To the best of our knowledge, there is no current research addressing the role of wheat bran enema as adjuvant therapy in pediatric patients with CAP. In order to investigate the effect of wheat bran enema, we analyzed clinical, imaging and laboratory data regarding inflammatory and anti-inflammatory cytokine profiles in patients with CAP.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The first group includes 18 patients who will receive conventional treatment and wheat bran enema.
Interventions/Control_2
The second group includes 21 patients who will receive conventional treatment only.
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
| 1 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients>1 month and up to 6 years diagnosed with lower respiratory tract infection admitted to Children Hospital, Faculty of Medicine, Assiut University during the study period
Key exclusion criteria
Patients age less than one month and more than six years
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Assiut University
Division name
Pediatric department
Zip code
71515
Address
Assiut University
TEL
+20882368373
khaled.ali@med.au.edu.eg
Public contact
Name of contact person
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Assiut University
Division name
Pediatric department
Zip code
71515
Address
Assiut University
TEL
+20882368373
Homepage URL
khaled.ali@med.au.edu.eg
Sponsor or person
Institute
Assiut university
Asyut Egypt
Institute
Department
Personal name
Funding Source
Organization
Assiut university
Asyut Egypt
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Egyptian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Assiut university Asyut Egypt
Address
Assiut university Asyut Egypt
Tel
+20882368373
Asmaa.zahran@aun.edu.eg
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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Assiut University (approval number 17300398; date 3-June 2020)
Publication of results
Unpublished
Result
URL related to results and publications
Assiut University (approval number 17300398; date 3-June 2020)
Number of participants that the trial has enrolled
39
Results
The WBE group showed a significant improvement in respiratory rate and respiratory score, with 20% of the patients transitioning from moderate to mild and 80% of the patients achieving a normal respiratory score, oxygen saturation from 92.9 to 96.
Results date posted
| 2023 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Initially, fifty patients were enrolled in this study, but only 39 patients (25 males and 14 female) completed the study, while 11 patients could not complete the study due to death or transfer to the Pediatric Intensive Care Unit (PICU). The 39 patients who completed the study were divided into two groups: 18 cases in the WBE group and 21 cases in the non-WBE group, with twenty-one children serving as the control group.
Participant flow
WBE can enhance the effectiveness of traditional CAP treatment and lead to rapid improvement in lower respiratory tract infections in children.
Adverse events
none
Outcome measures
WBE can enhance the effectiveness of traditional CAP treatment and lead to rapid improvement in lower respiratory tract infections in children.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053973
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