Surgical Infants Requiring Total Parenteral NutritionPhase 4NCT00647036
Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine
A Phase 4 study testing Isonitrogenous Vaminolact and Dipeptiven (L-glutamine- Lalanine) in people with Surgical Infants Requiring Total Parenteral Nutrition, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Surgical Infants Requiring Total Parenteral Nutrition
- What is being tested?
- Isonitrogenous Vaminolact and Dipeptiven (L-glutamine- Lalanine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to May 2012
- Phase
- Phase 4
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants who have undergone surgical procedures for congenital anomalies or
- Intestinal inflammation who require total parenteral nutrition.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Child Health, 30 Guilford Street
London, WC1N 1EH
About this study
Official title: Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.
We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.
- Being tested
- Isonitrogenous Vaminolact, Dipeptiven (L-glutamine- Lalanine)
- Keywords
- Parenteral nutrition, Infants, Dipeotiven, Microbial invasion
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isonitrogenous VaminolactDietary supplement
Isonitrogenous Vaminolact
Dipeptiven (L-glutamine- Lalanine)Drug
0.6g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dipeptiven (L-glutamine- Lalanine) Receives: Drug: Dipeptiven (L-glutamine- Lalanine) |
| 2 | Placebo comparator | Isonitrogenous Vaminolact Receives: Dietary Supplement: Isonitrogenous Vaminolact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of microbial invasion
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Infants Requiring Total Parenteral 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647036
- Sponsor's protocol ID
- 07SG10
- Status last verified
- Jan 2022
- First submitted
- 26 Mar 2008
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Bishay M, Simchowitz V, Harris K, Macdonald S, De Coppi P, Klein N, Eaton S, Pierro A; MIGS Trial Group. The Effect of Glutamine Supplementation on Microbial Invasion in Surgical Infants Requiring Parenteral Nutrition: Results of a Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Jan;44(1):80-91. doi: 10.1002/jpen.1700. Epub 2019 Sep 9.
PubMed 31502272
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.
- ClinicalTrials.gov ID
- NCT00647036
- Acronym / sponsor ID
- 07SG10
- Keywords
- Parenteral nutrition, Infants, Dipeotiven, Microbial invasion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Mar 2008 (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.
We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Dipeptiven (L-glutamine- Lalanine)Dipeptiven (L-glutamine- Lalanine) |
| 2 | Placebo comparator | Dietary Supplement: Isonitrogenous VaminolactIsonitrogenous Vaminolact |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants who have undergone surgical procedures for congenital anomalies or
- Intestinal inflammation who require total parenteral nutrition.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Isonitrogenous VaminolactIsonitrogenous Vaminolact | Dietary supplement | 2 |
| Dipeptiven (L-glutamine- Lalanine)0.6g/kg/day | Drug | 1 |
Primary outcome
Evidence of microbial invasion
Time frame: 5 days
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 25 Jan 2022.
- Results publication: PubMed 31502272Bishay M, Simchowitz V, Harris K, Macdonald S, De Coppi P, Klein N, Eaton S, Pierro A; MIGS Trial Group. The Effect of Glutamine Supplementation on Microbial Invasion in Surgical Infants Requiring Parenteral Nutrition: Results of a Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Jan;44(1):80-91. doi: 10.1002/jpen.1700. Epub 2019 Sep 9.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isonitrogenous Vaminolact and Dipeptiven (L-glutamine- Lalanine) in people with Surgical Infants Requiring Total Parenteral Nutrition, run by Institute of Child Health at 1 site in United Kingdom.
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 2 inclusion and 1 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evidence of microbial invasion (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647036, which also lists 1 linked publication.
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 25 Jan 2022.