Background
Fecal microbiota transplantation (FMT) is a promising new strategy in the treatment of Inflammatory Bowel Disease, but long-term delivery systems are lacking. This randomized study was designed as a safety and feasibility study of long-term FMT in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT).
Methods
Subjects were randomized 1:1 to receive FMT induction by colonoscopy, followed by 12 weeks of daily oral administration of frozen encapsulated cFMT or sham therpay. Subjects were followed for 36 weeks and longitudenal clinical assessments included multiple subjective and objective markers of disease severity. Ribosomal 16S bacterial sequencing was used to assess donor-induced changes in the gut microbiota. Changes in T regulatory (Treg) and mucosal associated invariant T (MAIT) cell populations were evaluated by flow cytometry as an exploratory endpoint.
Results
Twelve subjects with active UC were randomized: 6 subjects completed the full 12-week course of FMT plus cFMT, and 6 subjects received sham treatment by colonic installation and longitudinal oral placebo capules. Chronic administration of cFMT was found to be safe and well-tolerated but home storage concerns exist. Protocol adherence was high, and none of the study subjects experienced FMT-associated treatment emergent adverse events. Two subjects that received cFMT achieved clinical remission versus none in the placebo group (95% CI = 0.38-infinity, p = 0.45). cFMT was associated with sustained donor-induced shifts in fecal microbial composition. Changes in MAIT cell cytokine production were observed in cFMT recipients and correlated with treatment response.
Conclusion
These pilot data suggest that daily encapsulated cFMT may extend the durability of index FMT-induced changes in gut bacterial community structure and that an association between MAIT cell cytokine production and clinical response to FMT may exist in UC populations. Oral frozen encapsulated cFMT is a promising FMT delivery system and may be preferred for longterm treatment strategies in UC and other chronic diseases but further evaluations will have to address home storage concerns. Larger trials should be done to explore the benefits of cFMT and to determine its long-term impacts on the colonic microbiome. Trial registration: ClinicalTrials.gov (NCT02390726). Registered 17 March 2015, https://clinicaltrials.gov/ct2/show/NCT02390726?term=NCT02390726&draw=2&rank=1.
JEL classification: C93 D64 H41 Q20 C70Keywords: Altruism Common pool resources Conformity Experiments Reciprocity a b s t r a c t This paper develops and tests several models of pure Nash strategies of individuals who extract from a common pool resource when they are motivated by a combination of selfinterest and preferences for altruism, reciprocity, inequity aversion, or conformity. Using data from experiments conducted in three regions of Colombia that depend critically on a local fishery, we test whether an econometric summary of the subjects' pure Nash strategies is consistent with one or more of these models. We find that a model that balances selfinterest with a strong preference for conformity best describes average strategies.
As an example, Colombia recently launched the Visión Amazonía project, which will invest US$ 200 million (50% donated by international donors) until 2020 to halt deforestation processes completely. This project will be based on direct payments to landholders, and complemented by the BIOREDD+ program in Colombia, which aims to invest an additional US$ 27,8 million to promote sustainable livelihoods compatible with forest conservation.
Abstract:This paper uses experimental data to test for a complementary relationship between formal regulations imposed on a community to conserve a local natural resource and nonbinding verbal agreements to do the same. Our experiments were conducted in the field in three regions of Colombia. Each group of five subjects played 10 rounds of an open access common pool resource game, and 10 additional rounds under one of five institutions-communication alone, two external regulations that differed by the level of enforcement, and communication combined with each of the two regulations. Our results suggest that the hypothesis of a complementary relationship between communication and external regulation is supported for some combinations of regions and regulations, but cannot be supported in general. We therefore conclude that the determination of whether formal regulations and informal communication are complementary must be made on a community-by-community basis.
AcknowledgementsWe are grateful to Maria Claudia Lopez and members of the Faculty of Environmental and Rural Studies at Javeriana University in Bogotá, Colombia who provided outstanding support for our work in the field. At each site, the experiments would not have been possible without the assistance of local community leaders that helped the research team develop credibility with local community members. We are also indebted to WWF-Colombia for coordinating the fieldwork in the Pacific Region. We received valuable comments and ideas from Sylvia Brandt, James Boyce, Juan Camilo Cardenas, and Samuel Bowles. Wendy Varner and Susanne Hale provided valuable administrative support. We assume complete responsibility for the final contents of this paper. Abstract: This paper uses experimental data to test for a complementary relationship between formal regulations imposed on a community to conserve a local natural resource and nonbinding verbal agreements to do the same. Our experiments were conducted in the field in three regions of Colombia. Each group of five subjects played 10 rounds of an open access common pool resource game, and 10 additional rounds under one of five institutions-communication alone, two external regulations that differed by the level of enforcement, and communication combined with each of the two regulations. Our results suggest that the hypothesis of a complementary relationship between communication and external regulation is supported for some combinations of regions and regulations, but cannot be supported in general. We therefore conclude that the determination of whether formal regulations and informal communication are complementary must be made on a community-by-community basis.JEL Classification: C93, H41, Q20, Q28.
In the European context, these concerns are strongly associated with a European Green Deal, with investment in renewables and with digitization. References
This research is an empirical examination of institutional developments in Afro-Colombian communities that have occurred since the change in the property rights regime in 1991. I surveyed 82 local leaders of 42 communities to understand whether these communities have succeeded in designing and implementing rules to manage their collective land and its resources. I found that the new property regime has not replaced individuals' informal land holdings, which are still managed as de facto individual private property and are traded in the informal land market. However, the process of collective titling has changed local environmental governance by creating local rules and legal tools to guard against encroachment by intruders. Beyond the establishment of formal property rights, the process of community and authority building based on the expectation of collective titling has begun to formalize the management of the territory. Communities with and without collective titles have promoted new rules and procedures to manage their resources. However, monitoring and enforcement of the rules are weaker than expected.
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