GastroscopyNCT05219136
Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol
A study testing Modified Fasting Group and Conventional Fasting Group in people with Gastroscopy and Feelings, run by Changhai Hospital at 2 sites in China.
Trial summary
This double-center, prospective, interventional study aims to include 200 gastroscopic procedures and investigate the relationship between fasting time and feeling of subjects. The subjects will all receive examination between 10:30 to 11:30am. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroscopy, Feelings, Fasting
- What is being tested?
- Modified Fasting Group and Conventional Fasting Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 7 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)
Who cannot join
- Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endoscopists
- Emergency endoscopy and therapeutic endoscopy
- Subjects with history of esophageal or stomach surgery or endoscopic surgery
- Pregnant
- Subjects that refuse to cooperate with data collection or sign the informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
Luzhou, Sichuan
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol：a Double-center, Prospective, Controlled Study
This double-center, prospective, interventional study aims to include 200 gastroscopic procedures and investigate the relationship between fasting time and feeling of subjects. The subjects will all receive examination between 10:30 to 11:30am. In the control group, the subjects are required to start the fast at 10:00pm the day before examination and can not drink water after 8:00am on the day of examination. In the test group, the subjects are required to have customized rice congee before 6:30am on the examination day and can not drink water after 8:00am. All subjects complete questionnaire which include discomfort and willingness to accept the same fasting regimen.
- Conditions
- Gastroscopy, Feelings, Fasting
- Being tested
- Modified Fasting Group, Conventional Fasting Group
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Fasting GroupOther
a new fasting protocol is applied to subjects.
Conventional Fasting GroupOther
a conventional fasting protocol is applied to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Fasting Group | Active comparator | In this parallel group, subjects are performed a conventional fasting protocol which requires 6-8h fasting for solid, 2h for clear liquids. Receives: Other: Conventional Fasting Group |
| Modified Fasting Group | Experimental | In this test group, a new protocol of 4h fasting for rice porridge, 2h for clear liquids is applied to subjects.
The rice porridge is commercially available (New Rice Porridge®, Charm Kitchen Food Co., Ltd., Q/NBBD0001S). The volume is 300ml, with the energy as 105kJ per 100g, and it can be eaten after being heated or at room temperature. Receives: Other: Modified Fasting Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
subject's discomfort
The feeling of the subject during the examination. 1) the score of mucosal restriction observed under gastroscope 2）the score of discomfort before gastroscopy 3）the score of discomfort during gastroscopy process. The discomfort feeling indicator was obtained from subject through a VAS scale. The score of mucosal restriction was obtained from endoscopists.
Measured: up to 1 week
Secondary outcomes (1)
incidence of adverse events
number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start7 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroscopyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Lei Xin, Dr, Principal investigator, Changhai HospitalLuo-wei Wang, PhD, Study chair, Changhai HospitalLi Li, Dr, Principal investigator, The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219136
- Sponsor's protocol ID
- Fasting time
- Status last verified
- May 2022
- First submitted
- 20 Dec 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol：a Double-center, Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT05219136
- Acronym / sponsor ID
- Fasting time
- Conditions
- Gastroscopy, Feelings, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-center, prospective, interventional study aims to include 200 gastroscopic procedures and investigate the relationship between fasting time and feeling of subjects. The subjects will all receive examination between 10:30 to 11:30am. In the control group, the subjects are required to start the fast at 10:00pm the day before examination and can not drink water after 8:00am on the day of examination. In the test group, the subjects are required to have customized rice congee before 6:30am on the examination day and can not drink water after 8:00am. All subjects complete questionnaire which include discomfort and willingness to accept the same fasting regimen.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Fasting Group | Active comparator | Other: Conventional Fasting GroupIn this parallel group, subjects are performed a conventional fasting protocol which requires 6-8h fasting for solid, 2h for clear liquids. |
| Modified Fasting Group | Experimental | Other: Modified Fasting GroupIn this test group, a new protocol of 4h fasting for rice porridge, 2h for clear liquids is applied to subjects. The rice porridge is commercially available (New Rice Porridge®, Charm Kitchen Food Co., Ltd., Q/NBBD0001S). The volume is 300ml, with the energy as 105kJ per 100g, and it can be eaten after being heated or at room temperature. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)
Key exclusion criteria (5 listed)
- Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endoscopists
- Emergency endoscopy and therapeutic endoscopy
- Subjects with history of esophageal or stomach surgery or endoscopic surgery
- Pregnant
- Subjects that refuse to cooperate with data collection or sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Fasting Groupa new fasting protocol is applied to subjects. | Other | Modified Fasting Group |
| Conventional Fasting Groupa conventional fasting protocol is applied to subjects. | Other | Conventional Fasting Group |
Primary outcome
subject's discomfort
Time frame: up to 1 week
The feeling of the subject during the examination. 1) the score of mucosal restriction observed under gastroscope 2）the score of discomfort before gastroscopy 3）the score of discomfort during gastroscopy process. The discomfort feeling indicator was obtained from subject through a VAS scale. The score of mucosal restriction was obtained from endoscopists.
1 secondary outcome
incidence of adverse events
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Xin, Dr principal investigator
Changhai Hospital
Luo-wei Wang, PhD study chair
Changhai Hospital
Li Li, Dr principal investigator
The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Fasting Group and Conventional Fasting Group in people with Gastroscopy and Feelings, run by Changhai Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subject's discomfort (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.