Pilot study assessing the effects of poorly absorbed sugars in enteral formula on colonic gas production and symptom induction in healthy subjects

Pilot study assessing the effects of poorly absorbed sugars in enteral formula on colonic gas production in healthy subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000500752

Enrollment

Registered

2013-05-07

Start date

2013-04-03

Completion date

2013-04-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Diarrhoea amongst hospitalised patients receiving enteral formula (tube-feeding) is common. Previous research has suggested that one possible reason for this is the high content of poorly absorbed sugars called FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) in the formula. FODMAPs enter the large intestine where they get fermented by bacteria, produce gas and draw water in to the large intestine. In large enough doses, this may contribute to diarrhoea. We hypothesise that giving a formula we believe is high FODMAP compared to a formula we believe is low FODMAP will produce different amounts of large intestinal gas. This can be measure by collecting the breath after drinking these formulas and measuring the levels of gas in the breath. We will then compare this to a the FODMAP lactulose, which is a sugar that is known to produce gas in everyone. This will show us if there are FODMAPs in the formulas and a rough estimation of quantity.

Interventions

Participants will ingest (orally) one dose of the following fasted (on waking) before a minimum of two-day washout period before crossing over to all other arms: Arm 1 - 15g lactulose made up to 100mL solution Arm 2 - 500mL of enteral formula Isosource'Registered Trademark' HN Arm 3 - 500mL of enteral formula Isosource'Registered Trademark' 1.5 Arm 1 will be ingested first in all participants, then Arm 2 and Arm 3 will be allocated in random order determined by a computer-generated sequence.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Healthy subjects or subjects with functional gut symptoms such as irritable bowel syndrome over the age of 18 years

Exclusion criteria

1. Organic disease or condition predisposing the patient to diarrhoea (e.g. inflammatory bowel disease, bowel resection, untreated coeliac disease) 2. Non-breath hydrogen producer after lactulose ingestion 3. Use of antidiarrhoeal medications for one week prior to study commencement 4. Probiotic or prebiotic use for two weeks prior to study commencement 5. Antibiotic use for two weeks prior to study commencement

Outcome results