Enteral NutritionPhase 2/3NCT02353689
The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
A Phase 2/3 study testing low FODMAP, moderate FODMAP and high FODMAP in people with Enteral Nutrition, run by Oh Yoen Kim.
Trial summary
This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- low FODMAP, moderate FODMAP and high FODMAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 2/3
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tube-feeding patients
Who cannot join
- EN prohibited
- renal dysfunction (i.e. serum creatinine > 1.5 mg/dl or blood urea nitrogen > 25 mg/ml)
- liver dysfunction (i.e. serum aspartate aminotransferase > 40 U/L or alanine aminotransferase > 40 U/L)
- uncontrollable diabetes mellitus
- pregnancy, breast-feeding etc.
- severe diarrhea
About this study
Official title: Identification of the Effect of Fermentable Oligo-, di-, and Mono- Saccharides and Poorly Absorbed Short-chain Carbohydrate (FODMAP) Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.
Read the detailed description
A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .
- Conditions
- Enteral Nutrition
- Being tested
- low FODMAP, moderate FODMAP, high FODMAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FODMAPDietary supplement
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
moderate FODMAPDietary supplement
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
high FODMAPDietary supplement
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
| Study group | Role | What they receive |
|---|---|---|
| low FODMAP group | Experimental | consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention Receives: Dietary Supplement: low FODMAP |
| moderate FODMAP group | Experimental | consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention Receives: Dietary Supplement: moderate FODMAP |
| high FODMAP group | Experimental | consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention Receives: Dietary Supplement: high FODMAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
diarrhea
Measured: 14-day follow-up
Secondary outcomes (2)
prealbumin
Measured: 14-day follow-up
body mass index
Measured: 14-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oh Yoen Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A University
- Responsible party
- Sponsor-investigator, Oh Yoen Kim, Dong-A University
- Investigators
- Oh Yoen Kim, PhD, Principal investigator, Dong-A Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353689
- Sponsor's protocol ID
- 2-1040709-AB-N-01-201310-BR-03
- Status last verified
- Feb 2015
- First submitted
- 29 Jan 2015
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Effect of Fermentable Oligo-, di-, and Mono- Saccharides and Poorly Absorbed Short-chain Carbohydrate (FODMAP) Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
- ClinicalTrials.gov ID
- NCT02353689
- Acronym / sponsor ID
- 2-1040709-AB-N-01-201310-BR-03
- Conditions
- Enteral Nutrition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Oh Yoen KimUniversity, hospital or other
- Collaborators
- Dong-A University
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Feb 2015 (estimated)
- 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 study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.
Detailed description
A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low FODMAP group | Experimental | Dietary Supplement: low FODMAPconsumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention |
| moderate FODMAP group | Experimental | Dietary Supplement: moderate FODMAPconsumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention |
| high FODMAP group | Experimental | Dietary Supplement: high FODMAPconsumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- tube-feeding patients
Key exclusion criteria (6 listed)
- EN prohibited
- renal dysfunction (i.e. serum creatinine > 1.5 mg/dl or blood urea nitrogen > 25 mg/ml)
- liver dysfunction (i.e. serum aspartate aminotransferase > 40 U/L or alanine aminotransferase > 40 U/L)
- uncontrollable diabetes mellitus
- pregnancy, breast-feeding etc.
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 |
|---|---|---|
| low FODMAPconsumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention | Dietary supplement | low FODMAP group |
| moderate FODMAPconsumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention | Dietary supplement | moderate FODMAP group |
| high FODMAPconsumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention | Dietary supplement | high FODMAP group |
Primary outcome
diarrhea
Time frame: 14-day follow-up
2 secondary outcomes
prealbumin
Time frame: 14-day follow-up
body mass index
Time frame: 14-day follow-up
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 5 Feb 2015.
Related trials for Enteral Nutrition
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Oh Yoen Kim, PhD principal investigator
Dong-A Univeristy
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing low FODMAP, moderate FODMAP and high FODMAP in people with Enteral Nutrition, run by Oh Yoen Kim.
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 6 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 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
diarrhea (time frame: 14-day follow-up). 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 5 Feb 2015.