A double blind, randomized, placebo controlled, cross-over trial investigating the effect of High Amylose Maize Starch (HAMS) supplementation on fecal microbiological and inflammatory outcomes in individuals with Cystic Fibrosis and Healthy Volunteers.
Mater Misericordiae Ltd
20 participants
Apr 9, 2018
Interventional
Conditions
Summary
Cystic Fibrosis (CF) is associated with a significant increase in gut dysbiosis. Exposure to multiple courses of antibiotics as well as an inherently inflammatory gut contributes to this. We have shown that there are significant differences between the CF gut and healthy volunteers in these respects. High amylose maize starch (HAMS) is a pre-biotic food stuff produced in such a way as to encourage the production of beneficial, anti-inflammatory compounds. In laboratory culture, we have shown that HAMS increases the production of these compounds. What is not clear however is whether this laboratory data translates to a clinical benefit. This study will attempt to understand the impact of HAMS supplementation on the bacteria in the gut and the ability of the gut to make anti-inflammatory compounds, in adult patients with CF as well as in healthy control subjects.
Eligibility
Inclusion Criteria17
- Participated in the CF DYSBIOSIS study AND:
- Subjects aged 18 years or older with a diagnosis of CF as defined by:
- a. Presence of known CF causing genetic mutations in the CFTR OR
- b. Sweat chloride value >60 mmol/L OR
- c. Sweat chloride value <60 mmol/L must have documented evidence of chronic sinopulmonary disease manifested by (but not limited to):
- i. Persistent colonization/infection with typical CF pathogens, including Staphylococcus aureus, Haemophilus influenzae, and mucoid and nonmucoid Pseudomonas aeruginosa
- ii. Chronic cough and sputum production
- iii. Persistent chest radiograph abnormalities
- Nasal polyps, chronic sinusitis
- Able to provide informed consent.
- Willing and able to provide a stool sample and record a diet history.
- Stable CF disease as judged by the investigator.
- Participation in the CF DYSBIOSIS study AND
- No chronic respiratory disease, excepting well-controlled asthma (such subjects may be prescribed inhaled bronchodilators of any class, and/ or inhaled corticosteroids provided it is in low-dose, no more than 500 mcg/ day beclomethasone dose-equivalent).
- No antibiotic use (any class) in the prior 3 months.
- Able to provide informed consent.
- Willing and able to provide a stool sample and record a diet history.
Exclusion Criteria20
- CF participants will be considered ineligible to participate if:
- Did not participate in the CF DYSBIOSIS study.
- Have a toxigenic producing strain of C. difficile.
- Unable to provide informed consent due to:
- o Diminished understanding or comprehension.
- Evidence of active mucosal bowel disease
- Intolerance to high-fibre foods
- Any perceived contraindication to consumption of the test products.
- Additional antibiotic use in the last 1 month (above and beyond regular, baseline antibiotics and rotating nebulized antibiotics)
- Unwilling to provide consent.
- Healthy Control participants will be considered ineligible to participate if:
- Did not participate in the CF DYSBIOSIS study.
- A chronic respiratory disease other than well-controlled asthma.
- Consumption of any antibiotic in the prior 3 months.
- Unable to provide informed consent due to:
- o Diminished understanding or comprehension.
- Evidence of active mucosal bowel disease
- Intolerance to high-fibre foods
- Any perceived contraindication to consumption of the test products.
- Unwilling to provide consent.
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Interventions
Participants will be asked to consume prepacked 40g/d high amylose maize starch (HAMS) or 40g/day regular maize starch (RMS - Placebo) in a cross over fashion. Participants will consume the investigational product for 2 weeks, followed by a 2 week wash out prior to completing 2 further weeks of the alternate product. Each participant will act as their own control and the CF group will be compared to a Healthy control group undergoing the same intervention. HAMS is a well-described food supplement which contains approximately 70% amylose. It is used in a variety of food applications. It is generally regarded as safe (GRAF) by the FDA and has been used in healthy participants in clinical trials. HAMS and RMS will be provided in pre-packaged sachets. Participants will be asked to mix the supplement with 250 mL of liquid (for example milk, orange juice or water) and consume 40g/d in single, or in 2 divided doses. The resistant starch to be used is a standard food additive which is widely used globally. The constituents will be drug or food grade and supplied as follows: • HAMS = Hylon VII from Ingredion • RMS/Placebo = Mazaca 3401X from Ingredion, Both are drug grade products as specified by WHO and sourced by GD Pharma, a sterile pharmaceutical facility with TGA and cGMP accreditation. Adherence to the intervention will be monitored via packets returned at each visit. This will be monitored by both the dispensing pharmacy and the study coordinators
Locations(1)
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ACTRN12618000283279