UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062936 |
|---|---|
| Receipt number | R000072060 |
| Scientific Title | A study on the safety of administering konjac paste through a feeding tube in critically ill ICU patients |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/15 20:37:04 |
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Basic information
Public title
An exploratory study on the safety and feasibility of enteral tube administration of pouched konjac paste in critically ill patients receiving enteral nutrition in the intensive care unit
Acronym
KONJAC-Light Study
Scientific Title
A study on the safety of administering konjac paste through a feeding tube in critically ill ICU patients
Scientific Title:Acronym
KONJAC-Light Study
Region
| Japan |
Condition
Condition
Critically ill patients admitted to the intensive care unit (ICU) who are receiving enteral nutrition via a nasogastric tube or gastrostomy (PEG) tube; bowel management (diarrhea and constipation) during enteral nutrition
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early enteral nutrition is recommended for critically ill patients in the ICU, but diarrhea and constipation occur frequently during enteral nutrition management and often prevent adequate delivery of enteral nutrition. Glucomannan, the dietary fiber contained in konjac, has a bowel-regulating action and is expected to improve bowel management.
This study is a feasibility study conducted in preparation for a future randomized controlled trial of efficacy. A pouched konjac paste whose viscosity has been adjusted for enteral tube administration will be given through the feeding tube to ICU patients receiving enteral nutrition, in order to clarify the following:
Safety: incidence of gastrointestinal symptoms (diarrhea, abdominal distension) and of feeding tube trouble
Feasibility: smoothness of the administration process and the workload imposed on nursing staff
Exploratory efficacy: changes in stool frequency and stool consistency (preliminary data collection)
Prior to this clinical study, an in vitro preliminary experiment was performed on the prepared konjac paste product to evaluate its physical properties (line spread test, LST) and its passage through feeding tubes under simulated gastric fluid (pH 1-2) and simulated intestinal fluid (pH 7.0) conditions (37 degrees Celsius, 1 hour per phase). The mean LST value was 36 mm immediately after opening, and increased to 48 mm after 1 hour in the gastric phase and to 58 mm after 1 hour in the intestinal phase (up to 67 mm when mixed with an enteral formula), confirming increased flowability under conditions simulating the internal environment (reference value for enteral tube administration: LST 43 mm or greater). In the tube passage test, the konjac paste did not cause tube occlusion, and no residue was observed after flushing.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of enteral feeding tube occlusion during the 7-day intervention period. Occlusion is defined as a state in which infusion cannot be continued despite the specified injection procedure and flushing with 20 mL of lukewarm water, and which requires a recanalization procedure or replacement of the tube. Assessed at each administration and during the 24-hour observation on each study day.
Key secondary outcomes
Occurrence and timing of gastrointestinal symptoms (vomiting, diarrhea, severe abdominal distension ): assessed daily during the 7-day intervention period
Completion rate of administration: proportion of patients in whom the planned twice-daily administration was completed for 7 days
Stool frequency (per day): assessed daily during the 7-day intervention period
Time course of stool consistency assessed by the Bristol Stool Scale: assessed daily during the 7-day intervention period
Frequency of use of laxatives and enemas: assessed daily during the 7-day intervention period
Gastric residual volume: assessed daily during the 7-day intervention period
Time required for administration and nursing staff self-assessment of workload: at each administration
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
| Food |
Interventions/Control_1
In addition to routine enteral nutrition management, all 10 enrolled patients receive pouched konjac paste with viscosity adjusted for enteral tube administration (prepared by ORIHIRO Plandu Co., Ltd.).
Dose: one pouch (100 mL) per administration, twice daily.
Procedure: the pouch is connected to the connector of the enteral feeding tube and the content is injected; the tube is then flushed with 20 mL of lukewarm water.
Duration: 7 days from the start of the intervention, ending at discharge from the ICU or at the start of oral intake.
During the intervention period, the attending physician performs a daily abdominal examination and checks the condition of the feeding tube. Stool frequency, stool consistency and related items are recorded daily; these are observations within the scope of routine clinical care.
Discontinuation criteria: administration is stopped immediately in the event of worsening abdominal distension, vomiting, feeding tube occlusion, severe diarrhea, or any other situation in which the physician judges that continuation is difficult.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older admitted to the Emergency and Critical Care Center (ICU) of Ota Memorial Hospital
2. Patients in whom enteral nutrition via a nasogastric tube or gastrostomy (PEG) tube is being started
3. Patients in whom enteral nutrition is expected to continue for 7 days or longer
4. Patients from whom written informed consent has been obtained, either from the patient or from a legally acceptable representative
Key exclusion criteria
1. Patients with a history or suspicion of gastrointestinal obstruction (ileus)
2. Patients immediately after gastrointestinal surgery, or with active gastrointestinal bleeding
3. Patients with unstable hemodynamics and a high risk of intestinal ischemia
4. Patients using an enteral feeding tube smaller than 12 Fr, in whom the risk of occlusion is judged to be high
5. Patients with konjac allergy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | KEIJI |
| Middle name | |
| Last name | SAKURAI |
Organization
Subaru Health Insurance Society Ota Memorial Hospital
Division name
Department of Emergency Medicine
Zip code
3738585
Address
455-1 Oshima-cho, Ota, Gunma, Japan
TEL
0276552200
sakuraikeiji76@gmail.com
Public contact
Name of contact person
| 1st name | KEIJI |
| Middle name | |
| Last name | SAKURAI |
Organization
Subaru Health Insurance Society Ota Memorial Hospital
Division name
Department of Emergency Medicine
Zip code
3738585
Address
455-1 Oshima-cho, Ota, Gunma, Japan
TEL
0276552200
Homepage URL
sakuraikeiji76@gmail.com
Sponsor or person
Institute
Subaru Health Insurance Society Ota Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Subaru Health Insurance Society Ota Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
ORIHIRO Plandu Co., Ltd. (collaborates in the preparation of the investigational pouched konjac paste)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Subaru Health Insurance Society Ota Memorial Hospital
Address
455-1 Oshima-cho, Ota, Gunma , Japan
Tel
0276552200
sakuraikeiji76@gmail.com
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
SUBARU健康保険組合太田記念病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
No plan to share IPD
IPD sharing Plan description
There is no plan to provide anonymized individual participant data to external parties in this study.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072060
