Clinical Trial: Effect of Azithromycin on Oesophageal Hypomotility
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect Of Azithromycin On Oesophageal Function In Patients With Dysphagia Or Gastro-Oesophageal Reflux Associated With Frequent Oesophageal Hypomotility
Brief Summary:
Patients with difficulty in swallowing (dysphagia) or with reflux disease are frequently found to suffer from oesophageal hypomotility (weak contractions).
Oesophageal motility is currently measured using high-resolution manometry (HRM). This technique has a 36 pressure sensors on a plastic tube to record the pressure in side the oesophagus.
Several pharmaceutical agents (prokinetics) can stimulate oesophageal motility. However, use of prokinetics in patients with oesophageal hypomotility led to disappointing results. An explanation for these disappointing results is that inappropriate patients were targeted. The appropriate patient would be the one who still have some viable muscle in the oesophagus that can respond to pharmacological stimuli.
In the process of developing treatment strategies in patients with oesophageal hypomotility, testing the preserved capacity of oesophageal muscles could be useful to predict the response of these patients to prokinetic drugs. The following tests have the potential to reveal the preserved capacity of the oesophageal muscle to respond to stronger/medicinal stimuli.
- - Multiple rapid swallowing (MRS) of 5ml water boluses stimulates oesophagus. A normal response to MRS requires on the one hand integrity of neural mechanisms and on the other hand a functional oesophageal muscle.
- - External abdominal compression can increase the resistance to bolus transport via oesophagus. The normal oesophagus produces contractions of higher amplitude and duration in order to maintain a normal bolus transit.
- - Swallowing bread boluses require stronger oesophageal contractions for a successful bolus transit
Detailed Summary:
Sponsor: JAFAR JAFARI
Current Primary Outcome: Effect of Azithromycin on oesophageal peristalstic contraction amplitude in patients with hypomotility [ Time Frame: 4 weeks ]
The amplitude of peristaltic contractions and also Distal Contractal Integral which summarises the vigour of peristalsis will be measured before and after treatment with Azithromycin. Measurement is performed by oesophageal high resolution manometry. The measures will be compared to decide on the effect oo Azithromycin on oesophageal motility.
Original Primary Outcome: Effect of Azithromycin on oesophageal hypomotility
Current Secondary Outcome: Manometric oesophageal body response (amplitude of peristaltic contractions in mmHg and also Distal Contractal Integral in mmHg.cm.second) to solid bolus swallows, MRS and outlet obstruction in healthy subjects and patients with oesophageal hypomotility. [ Time Frame: 4 weeks ]
The above parameters will be measured before and after treatment with Azithromycin. Measurement is performed by oesophageal high resolution manometry. The measures will be compared to decide on the effect oo Azithromycin on oesophageal motility.
Original Secondary Outcome: Manometric oesophageal body response to solid bolus swallows, MRS and outlet obstruction in healthy subjects and patients with oesophageal hypomotility.
Information By: Queen Mary University of London
Dates:
Date Received: September 30, 2011
Date Started: August 2012
Date Completion:
Last Updated: April 21, 2015
Last Verified: April 2015
