What is the prevalence of gastro-intestinal disorders and which are the determinants?
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of:
- Inflammation, ulcerations and erosions of the gastrointestinal tract,
including peptic ulcers
- Barrets esophagus
- Celiac disease
- Gastrointestinal bleeding
- Small bowel polyps
- Large bowel polyps
Secondary outcome
In this study, the entire digestive tract imaged. As a result, the research
provides information about the entire gastro-intestinal tract. These images are
relevant and of great value because they reveal information about prevalence of
diseases in the general asymptomatic population. ERGO hereby provides the
unique ability to relate this information to factors such as drug use, medical
history, and other determinants. In addition, the findings are compared with
the findings at endoscopy if subjects are referred for endoscopy.
Recently, an association was made between the microbiome and microRNA (miRNA)
and carcinogenesis. The gut microbiome consists of 100 trillion micro-organisms
in the gut and has an important immune, structural, metabolic and defence
function in the gut. MiRNAs are small non-coding regulatory RNAs with sizes of
20-24 nucleotides. Their function in the human genome consists of the
regulation of gene expression. Both microbiome and miRNA could be involved in
the carcinogenesis. To further explore the involvement in carcinogenesis, it is
necessary to know the composition of the microbiome and miRNA in healthy
individuals.
Background summary
The Rotterdam Elderly Study is a prospective cohort study in the Ommoord
district in the city of Rotterdam, the Netherlands [Hofman et al., 1991].
Gastro intestinal diseases are common in the elderly population but accurate
figures are unknown, partly because it is present without symptoms. For this
reason, the true prevalence in the general population is unknown, mainly since
most studies are performed in symptomatic populations. Video Capsule endoscopy
(VCE) provides images of the entire gastrointestinal tract and can tehrefore be
used to identify gastro-intestinal disorders.
Study objective
What is the prevalence of gastro-intestinal disorders and which are the
determinants?
Study design
ERGO participants are invited by mail for this additional study by means of
video capsule endoscopy. The study procedure mainly takes place at the
participant's home, only ingestion of the capsule with application and
activation of the sensor belt with data recorder takes place at the ERGO
research center in Rotterdam.
Intervention
Participants are invited to videocapsule endoscopy (VCE) screening using the
Pillcam colon 2L (Given Imaging ltd. Israel). Colon cleansing consists of a
Senna tablet (Sennocol 185 mg; Meda Pharma BV, Amstelveen, The Netherlands) at
bedtime 2 days before CCE. Subsequently all participants will start a liquid
diet at 13:00 the day before VCE and will receive 2 liter of polyethylene
electrolyte glycol solution (Moviprep; Norgine, Amsterdam, The Netherlands) and
2 liter transparent fluid, split-dose. Booster during VCE procedure consists of
additional 250ml Eziclen boost and an optional 250ml Eziclen boost, each
followed by about 0.5 liter of clear liquids. The second administration is an
optional booster, 3 hours after the first booster which participants will only
be instructed to drink in case the capsule has not already been excreted.
Procedure ends 10 hours after ingestion.
Participants are asked twice to complete a questionnaire about the expected and
perceived burden; it will take 5-10 minutes to complete one questionnaire.
Participants are asked to perform a stool test (FIT)
Study burden and risks
Potential adverse events associated with the use of Pillcam colon 2L may
include obstruction or retention of the capsule. Capsule retentions can be
resolved by either laxative ingestion or removal of the capsule during
colonoscopy or in very rare cases surgery. The procedure involves laxatives and
prokinetic agents. See the SPC-texts of metoclopramide, moviprep, eziclen or
bisacodyl for possible adverse events. It is made clear that participation is
completely voluntary.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- 50-74 years
- participant Rotterdam study
Exclusion criteria
- Inability or refusal to provide informed consent.
- Persons with a severe or terminal disease with a life-expectancy of less than 5 years.
- An allergy or any other known contraindication to the medication used in this study
- Renal failure, eGFR <30 ml/min/1.73m2
- Congestive heart failure NYHA class III or IV
- Dysphagia or other swallowing disorder which makes it impossible to swallow the capsule.
- High risk of capsule retention: IBD, Personal history of gastrointestinal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Cardiac pacemakers or other implanted electro-medical equipment.
- An MRI scheduled within 14 days after ingestion of the capsule.
- Patients with diagnosed or suspected Congenital Long QT Syndrome
- Patients with concomitant use of drugs that prolong the QT interval
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53967.078.15 |