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

NCT05693259 | Completed

• 1 other identifier: EMB-2022-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (3)

• functional dyspepsia-related quality of life (FD-QoL),

  6 weeks

• Korean version of the Nepean Dyspepsia Index (NDI-K)

  6 weeks

• Inflammatory cytokines

  6 weeks

Study Arms (2)

EARW group

EXPERIMENTAL

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.

Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer

PW group

SHAM COMPARATOR

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.

Device: Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer

Interventions

Electrolyzed Alkaline Reduced Water (EARW) generated from electrolyzed ionizer DEVICE

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.

Also known as: Purified water (PW) generated from sham device

EARW group; PW group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gwando, 26426, South Korea

Location

Study Officials

• Kyu-Jae Lee, Ph.D.

  20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * Control group (PW): purified water-drinking group * Experimental group (EARW): Electrolyzed alkaline reduced water drinking group

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 20, 2023
• Study Start: August 10, 2022
• Primary Completion: October 28, 2022
• Study Completion: November 29, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)