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Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer
Sponsored by
Wonju Severance Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, epigastric burning sensation) No evidence of structural disease in gastroscopy within the last 3 months Aged 19-70 years Who meets Rome IV criteria for functional dyspepsia Who have 4 or more symptoms based on the gastrointestinal symptom rating scale Patients who voluntarily agree to participate in this study and sign a written consent Exclusion Criteria: Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded Subjects who have uncontrolled diabetes and hypertension despite appropriate management Subjects who have a history of peptic ulcer or reflux esophagitis within the past 6 months were excluded Subject who have history of gastrointestinal surgery were excluded Women who are pregnant or breastfeeding Subjects who are taking drugs that may affect the gastrointestinal tract (minimum of 2 weeks washout period is necessary before participating in the trial (Medications include H2 receptor blockers, anticholinergics, prostaglandins, proton pump inhibitors, gastromucosal protection agents, corticosteroids, non-steroidal anti-inflammatory drugs, aspirin, mucosal protective agents, etc.) Subjects who are under drugs for therapeutic purposes such as functional food that promotes gastric health Subjects who consumed more than 14 times alcohol per week in case of man and 7 times per week in case of female in the past 1 month

Sites / Locations

  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

EARW group

PW group

Arm Description

Patients in EARW group drink EARW (pH 9.5) 10 mL/kg body weight per a day using experimental device installed in the house for 6 weeks. We recommend to drink water in empty stomach three or four times a day. The water generated from device will be administered immediately, not to be stored.

Patients in PW group drink PW (pH 9.5) 10 mL/kg body weight per a day using Sham device installed in the house for 6 weeks. We recommend to drink water in empty stomach three or four times a day. The water generated from device will be administered immediately, not to be stored. Sham device was built in the same shape and operation as the experimental device.

Outcomes

Primary Outcome Measures

gastrointestinal symptom rating scale (GSRS)
The GSRS is a survey questionnaire designed to assess the symptoms associated with common GI disorders. It includes 15 questions on a scale of 1-7 that assess the inconvenience of the symptoms over the preceding period. A higher GSRS score indicates more inconvenient symptoms.

Secondary Outcome Measures

functional dyspepsia-related quality of life (FD-QoL),
The FD-QoL questionnaire was used to measure the quality of life of FD patients. It includes total 21 items, and is categorized into 4: eating/diet (five items), daily activity (four items), emotion (six items), and social functioning (six items) on a 5-point Likert scale. A higher score indicates worse QoL.
Korean version of the Nepean Dyspepsia Index (NDI-K)
The NDI-K is a validated tool used for evaluating clinically meaningful FD changes, symptoms related to gastrointestinal problems. and it includes 15 symptom-based questions.
Inflammatory cytokines
Interleukin (IL)-1β, IL-10, IL-6, tumor necrosis factor (TNF)-α, and interferon gamma (IFN-γ) levels were measured to observe inflammatory immune response

Full Information

First Posted
December 8, 2022
Last Updated
January 12, 2023
Sponsor
Wonju Severance Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05693259
Brief Title
Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer
Official Title
Improvement Effect of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer in Functional Ddyspepsia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonju Severance Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the effect of drinking electrolyzed alkaline reduced water (EARW) compared to drinking purified water (PW) on functional dyspepsia (FD) patients. The main question[s] it aims to answer are: Drinking EARW (EARW group) will alleviate gastrointestinal (GI) symptoms and FD symptoms compared to drinking PW (PW group). Drinking EARW will make higher the FD-related Quality of Life (FD-QOL) compared to drinking PW. Patients will drink EARW 10mL/kg/day body weight for 6 weeks according to the instruction of researcher using the experimental device installed at each patient's house. After 6 week, EARW and PW groups will be compared to evaluate effect of GI symptom and FD-related QOL.
Detailed Description
This study was designed as a randomized, parallel, double-blind controlled clinical trial. Enrolled patients with FD will be allocated randomly into two groups: EARW group and PW group. For 6 weeks, the patients will drink EARW and PW (10mL/kg/day body weight) in empty stomach condition. For the primary outcome measure, the gastrointestinal symptom rating scale (GSRS) will be used, and for the secondary outcome measure functional dyspepsia-related quality of life (FD-QoL), and Korean version of the Nepean Dyspepsia Index (NDI-K) will be used at baseline and at 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group (PW): purified water-drinking group Experimental group (EARW): Electrolyzed alkaline reduced water drinking group
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EARW group
Arm Type
Experimental
Arm Description
Patients in EARW group drink EARW (pH 9.5) 10 mL/kg body weight per a day using experimental device installed in the house for 6 weeks. We recommend to drink water in empty stomach three or four times a day. The water generated from device will be administered immediately, not to be stored.
Arm Title
PW group
Arm Type
Sham Comparator
Arm Description
Patients in PW group drink PW (pH 9.5) 10 mL/kg body weight per a day using Sham device installed in the house for 6 weeks. We recommend to drink water in empty stomach three or four times a day. The water generated from device will be administered immediately, not to be stored. Sham device was built in the same shape and operation as the experimental device.
Intervention Type
Device
Intervention Name(s)
Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer
Other Intervention Name(s)
Purified water (PW) generated from sham device
Intervention Description
Patient will be allocated randomly to two groups: EARW and PW groups. For 6 weeks, patients drink water (10mL/kg body weight/day ) generated from the device installed in the house before starting intervention. Patients will be instructed to drink in empty stomach, and to drink immediately after generation of water. The total amount that the patient drank the day before will be monitored by a researcher using survey form of mobile phone everyday.
Primary Outcome Measure Information:
Title
gastrointestinal symptom rating scale (GSRS)
Description
The GSRS is a survey questionnaire designed to assess the symptoms associated with common GI disorders. It includes 15 questions on a scale of 1-7 that assess the inconvenience of the symptoms over the preceding period. A higher GSRS score indicates more inconvenient symptoms.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
functional dyspepsia-related quality of life (FD-QoL),
Description
The FD-QoL questionnaire was used to measure the quality of life of FD patients. It includes total 21 items, and is categorized into 4: eating/diet (five items), daily activity (four items), emotion (six items), and social functioning (six items) on a 5-point Likert scale. A higher score indicates worse QoL.
Time Frame
6 weeks
Title
Korean version of the Nepean Dyspepsia Index (NDI-K)
Description
The NDI-K is a validated tool used for evaluating clinically meaningful FD changes, symptoms related to gastrointestinal problems. and it includes 15 symptom-based questions.
Time Frame
6 weeks
Title
Inflammatory cytokines
Description
Interleukin (IL)-1β, IL-10, IL-6, tumor necrosis factor (TNF)-α, and interferon gamma (IFN-γ) levels were measured to observe inflammatory immune response
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, epigastric burning sensation) No evidence of structural disease in gastroscopy within the last 3 months Aged 19-70 years Who meets Rome IV criteria for functional dyspepsia Who have 4 or more symptoms based on the gastrointestinal symptom rating scale Patients who voluntarily agree to participate in this study and sign a written consent Exclusion Criteria: Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded Subjects who have uncontrolled diabetes and hypertension despite appropriate management Subjects who have a history of peptic ulcer or reflux esophagitis within the past 6 months were excluded Subject who have history of gastrointestinal surgery were excluded Women who are pregnant or breastfeeding Subjects who are taking drugs that may affect the gastrointestinal tract (minimum of 2 weeks washout period is necessary before participating in the trial (Medications include H2 receptor blockers, anticholinergics, prostaglandins, proton pump inhibitors, gastromucosal protection agents, corticosteroids, non-steroidal anti-inflammatory drugs, aspirin, mucosal protective agents, etc.) Subjects who are under drugs for therapeutic purposes such as functional food that promotes gastric health Subjects who consumed more than 14 times alcohol per week in case of man and 7 times per week in case of female in the past 1 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Jae Lee, Ph.D.
Organizational Affiliation
20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
Official's Role
Study Chair
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gwando
ZIP/Postal Code
26426
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer

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