Clinical trial NCT05693259: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Control group (PW): purified water-drinking group
* Experimental group (EARW): Electrolyzed alkaline reduced water drinking group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: gastrointestinal symptom rating scale (GSRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: functional dyspepsia-related quality of life (FD-QoL),
timeFrame: 6 weeks
measure: Korean version of the Nepean Dyspepsia Index (NDI-K)
timeFrame: 6 weeks
measure: Inflammatory cytokines
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gwando
Study officials:
affiliation: 20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
name: Kyu-Jae Lee, Ph.D.
role: STUDY_CHAIR
References: