PrebioticsEarly Phase 1HoneyNCT02679183
Medically-Graded Honey Supplementation Formula To Preterm Infants
A Early Phase 1 study testing Medically-Graded Honey and Premature Milk Formula in people with Prebiotics and Honey, run by Cairo University.
Trial summary
Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. Read more about this study
- Who is it for?
- Ages 3 days to 3 weeks
- Conditions the study is for
- Prebiotics, Honey, Premature Infants
- What is being tested?
- Medically-Graded Honey and Premature Milk Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Mar 2014
- Phase
- Early Phase 1
- 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 3 days to 3 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants with gestational age ≤ 34 weeks
- postnatal age > 3 days
- no previous enteral feeding, and
- parental wish to use milk formula with no intention to use breast milk or breastfeed.
Who cannot join
- infants with major chromosomal abnormalities
- Infant with major congenital anomalies of the cardiovascular, pulmonary or central nervous system; including neuromuscular disorders and neural tube defects
- infants with intestinal atresia, tracheoesophageal fistulas, omphalocele, gastroschisis, and other major congenital GI anomalies, and
- infants with sepsis, either before or during enrollment
About this study
Official title: Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants
Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. Investigators hypothesized that supplementation of enteral feeds with honey would produce a bifidogenic effect and stimulate the immune response in preterm infants. Investigators randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2 weeks and measured their effect on stool colonization, systemic immune parameters and anthropometric measurements.
- Conditions
- Prebiotics, Honey, Premature Infants, Intestinal Microbiota
- Being tested
- Medically-Graded Honey, Premature Milk Formula
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically-Graded HoneyDietary supplement
Honey added to the baby formula once a day for 2 weeks.
Premature Milk FormulaOther
Enteral feeds were provided to subjects of all groups using premature milk formula as per routine nutritional management in the neonatal intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Control 0 | Placebo comparator | No Intervention. This group received Premature Milk Formula. This group did not receive any Medically-Graded Honey. Receives: Other: Premature Milk Formula |
| Group 1 | Experimental | This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 5 gram/day) for 2 weeks Receives: Dietary Supplement: Medically-Graded Honey; Other: Premature Milk Formula |
| Group 2 | Experimental | This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 10 gram/day) for 2 weeks Receives: Dietary Supplement: Medically-Graded Honey; Other: Premature Milk Formula |
| Group 3 | Experimental | This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 15 gram/day) for 2 weeks Receives: Dietary Supplement: Medically-Graded Honey; Other: Premature Milk Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool
Stool culture/ Gram Stain and quantitative real time PCR were used to for this outcome.
Measured: Two weeks
Secondary outcomes (4)
CD4 and CD8 concentration in the serum
Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA
Measured: 2 weeks
Change in Weight (gram)
The difference between weight at enrollment and at 2 weeks was measured for all subjects
Measured: Baseline and 2 weeks
Change in crown-heel length (cm)
The difference between the length at enrollment and at 2 weeks was measured for all subjects
Measured: Baseline and 2 weeks
Change in head circumference (cm)
The difference between head circumference at enrollment and at 2 weeks was measured for all subjects
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PrebioticsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem N. Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679183
- Sponsor's protocol ID
- 100904
- Acronym
- Honey
- Status last verified
- Feb 2016
- First submitted
- 3 Feb 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
Publications
Boyar V, Handa D, Clemens K, Shimborske D. Clinical experience with Leptospermum honey use for treatment of hard to heal neonatal wounds: case series. J Perinatol. 2014 Feb;34(2):161-3. doi: 10.1038/jp.2013.158.
PubMed 24476663Eteraf-Oskouei T, Najafi M. Traditional and modern uses of natural honey in human diseases: a review. Iran J Basic Med Sci. 2013 Jun;16(6):731-42.
PubMed 23997898Ezz El-Arab AM, Girgis SM, Hegazy EM, Abd El-Khalek AB. Effect of dietary honey on intestinal microflora and toxicity of mycotoxins in mice. BMC Complement Altern Med. 2006 Mar 14;6:6. doi: 10.1186/1472-6882-6-6.
PubMed 16533410Kapiki A, Costalos C, Oikonomidou C, Triantafyllidou A, Loukatou E, Pertrohilou V. The effect of a fructo-oligosaccharide supplemented formula on gut flora of preterm infants. Early Hum Dev. 2007 May;83(5):335-9. doi: 10.1016/j.earlhumdev.2006.07.003. Epub 2006 Sep 14.
PubMed 16978805Aly H, Said RN, Wali IE, Elwakkad A, Soliman Y, Awad AR, Shawky MA, Alam MSA, Mohamed MA. Medically Graded Honey Supplementation Formula to Preterm Infants as a Prebiotic: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):966-970. doi: 10.1097/MPG.0000000000001597.
PubMed 28379925
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants
- ClinicalTrials.gov ID
- NCT02679183
- Acronym / sponsor ID
- Honey / 100904
- Conditions
- Prebiotics, Honey, Premature Infants, Intestinal Microbiota
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Feb 2016 (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.
Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. Investigators hypothesized that supplementation of enteral feeds with honey would produce a bifidogenic effect and stimulate the immune response in preterm infants. Investigators randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2 weeks and measured their effect on stool colonization, systemic immune parameters and anthropometric measurements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control 0 | Placebo comparator | Other: Premature Milk FormulaNo Intervention. This group received Premature Milk Formula. This group did not receive any Medically-Graded Honey. |
| Group 1 | Experimental | Dietary Supplement: Medically-Graded Honey, Other: Premature Milk FormulaThis group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 5 gram/day) for 2 weeks |
| Group 2 | Experimental | Dietary Supplement: Medically-Graded Honey, Other: Premature Milk FormulaThis group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 10 gram/day) for 2 weeks |
| Group 3 | Experimental | Dietary Supplement: Medically-Graded Honey, Other: Premature Milk FormulaThis group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 15 gram/day) for 2 weeks |
Who may qualify
- Ages
- 3 days to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- preterm infants with gestational age ≤ 34 weeks
- postnatal age > 3 days
- no previous enteral feeding, and
- parental wish to use milk formula with no intention to use breast milk or breastfeed.
Key exclusion criteria (4 listed)
- infants with major chromosomal abnormalities
- Infant with major congenital anomalies of the cardiovascular, pulmonary or central nervous system; including neuromuscular disorders and neural tube defects
- infants with intestinal atresia, tracheoesophageal fistulas, omphalocele, gastroschisis, and other major congenital GI anomalies, and
- infants with sepsis, either before or during enrollment
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 |
|---|---|---|
| Medically-Graded HoneyHoney added to the baby formula once a day for 2 weeks. | Dietary supplement | Group 1, Group 2, Group 3 |
| Premature Milk FormulaEnteral feeds were provided to subjects of all groups using premature milk formula as per routine nutritional management in the neonatal intensive care unit. | Other | Control 0, Group 1, Group 2, Group 3 |
Primary outcome
The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool
Time frame: Two weeks
Stool culture/ Gram Stain and quantitative real time PCR were used to for this outcome.
4 secondary outcomes
CD4 and CD8 concentration in the serum
Time frame: 2 weeks
Change in Weight (gram)
Time frame: Baseline and 2 weeks
Change in crown-heel length (cm)
Time frame: Baseline and 2 weeks
Change in head circumference (cm)
Time frame: Baseline and 2 weeks
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 10 Feb 2016.
- Results publication: PubMed 24476663Boyar V, Handa D, Clemens K, Shimborske D. Clinical experience with Leptospermum honey use for treatment of hard to heal neonatal wounds: case series. J Perinatol. 2014 Feb;34(2):161-3. doi: 10.1038/jp.2013.158.
- Results publication: PubMed 23997898Eteraf-Oskouei T, Najafi M. Traditional and modern uses of natural honey in human diseases: a review. Iran J Basic Med Sci. 2013 Jun;16(6):731-42.
- Results publication: PubMed 16533410Ezz El-Arab AM, Girgis SM, Hegazy EM, Abd El-Khalek AB. Effect of dietary honey on intestinal microflora and toxicity of mycotoxins in mice. BMC Complement Altern Med. 2006 Mar 14;6:6. doi: 10.1186/1472-6882-6-6.
- Results publication: PubMed 16978805Kapiki A, Costalos C, Oikonomidou C, Triantafyllidou A, Loukatou E, Pertrohilou V. The effect of a fructo-oligosaccharide supplemented formula on gut flora of preterm infants. Early Hum Dev. 2007 May;83(5):335-9. doi: 10.1016/j.earlhumdev.2006.07.003. Epub 2006 Sep 14.
- Derived from this study: PubMed 28379925Aly H, Said RN, Wali IE, Elwakkad A, Soliman Y, Awad AR, Shawky MA, Alam MSA, Mohamed MA. Medically Graded Honey Supplementation Formula to Preterm Infants as a Prebiotic: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):966-970. doi: 10.1097/MPG.0000000000001597.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Medically-Graded Honey and Premature Milk Formula in people with Prebiotics and Honey, run by Cairo University.
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 4 inclusion and 4 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 10 Feb 2016. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool (time frame: Two weeks). 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 NCT02679183, which also lists 5 linked publications.
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 10 Feb 2016.